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  • COMBINED ORAL CONTRACEPTIVES
  • PROGESTIN-ONLY ORAL CONTRACEPTIVES
  • EMERGENCY CONTRACEPTIVES
Econtra

EContra One-Step

(Levonorgestrel) Tablet, 1.5 mg

distributor product number:

AmerisourceBergen: 10186363
ANDA: 328092
ASD Healthcare: 52338
Cardinal: 5439013
Morris & Dickson: 246314
R&S Northeast: 021116
Seacoast Medical LLC: 500041
View full Product Information here

ella

ella®

ulipristal acetate tablet 30 mg

distributor product number:

AmerisourceBergen: 10153832
ANDA: 50102091101
ASD Healthcare: 46710
Cardinal: 5029780
McKesson: 3470556
Morris & Dickson: 602680
R&S Northeast: 091101
Seacoast Medical LLC: 500033
View full Prescribing Information here

Aubra

Aubra EQ®

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg

distributor product number:

AmerisourceBergen: 10189389
ANDA: 50102022023
ASD Healthcare: 52340
Cardinal: 5478490
Morris & Dickson: 392407
R&S Northeast: 0220230
Seacoast Medical LLC: 500043
View full Prescribing Information, including Boxed Warning, here

Chateal

Chateal EQ®

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg

distributor product number:

AmerisourceBergen: 10189487
ANDA: 50102023023
ASD Healthcare: 52341
Cardinal: 5478508
Morris & Dickson: 392530
R&S Northeast: 023023
Seacoast Medical LLC: 500044
View full Prescribing Information, including Boxed Warning, here

Cyred

Cyred EQ®

Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg

distributor product number:

AmerisourceBergen: 10189510
ANDA: 50102025423
ASD Healthcare: 52459
Cardinal: 5478516
Morris & Dickson: 392514
R&S Northeast: 025423
Seacoast Medical LLC: 500046
View full Prescribing Information, including Boxed Warning, here

Jasmiel

Jasmiel

Drosperinone and Ethinyl Estradiol Tablets, USP 3.0 mg/0.02 mg

distributor product number:

ANDA: 329302
ASD Healthcare: 54018
Cardinal: 5515960
Morris & Dickson: 584797
R&S Northeast: 024023
Seacoast Medical LLC: 500047
View full Prescribing Information, including Boxed Warning, here

Tarina 24 Fe

Tarina® 24 Fe

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1.0 mg/0.02 mg and 75 mg

distributor product number:

ANDA: 329348
ASD Healthcare: 54137
Cardinal: 5520002
Morris & Dickson: 591008
R&S Northeast: 022423
Seacoast Medical LLC: 500048
View full Prescribing Information, including Boxed Warning, here

Tarina

Tarina Fe 1/20 EQ®

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets,
1 mg/20 mcg/75 mg

distributor product number:

AmerisourceBergen: 10189488
ANDA: 50102022823
ASD Healthcare: 52458
Cardinal: 5478524
Morris & Dickson: 392795
R&S Northeast: 022823
Seacoast Medical LLC: 500045
View full Prescribing Information, including Boxed Warning, here

Tri-VyLibra

Tri-VyLibra®

Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg

distributor product number:

AmerisourceBergen: 10185559
ANDA: 328026
ASD Healthcare: 51976
Cardinal: 5423181
Morris & Dickson: 225896
R&S Northeast: 023313
Seacoast Medical LLC: 112407
View full Prescribing Information, including Boxed Warning, here

Tri-VyLibra Lo

Tri-VyLibra® Lo

Norgestimate and Ethinyl Estradiol Tablets, USP 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg

distributor product number:

ANDA: 329111
ASD Healthcare: 53776
Cardinal: 5507397
Morris & Dickson: 551184
R&S Northeast: 0231130
Seacoast Medical LLC: 112816
View full Prescribing Information, including Boxed Warning, here

tulana

Tulana

Norethindrone Tablets USP 0.35 mg

distributor product number:

AmerisourceBergen: 10187847
ANDA: 328268
ASD Healthcare: 52339
Cardinal: 5460522
Morris & Dickson: 269902
R&S Northeast: 020013
Seacoast Medical LLC: 500042
View full Prescribing Information, including Boxed Warning, here

VyLibra

VyLibra®

Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg

distributor product number:

AmerisourceBergen: 10185558
ANDA: 328025
ASD Healthcare: 51977
Cardinal: 5423173
Morris & Dickson: 225870
R&S Northeast: 023513
Seacoast Medical LLC: 112406
View full Prescribing Information, including Boxed Warning, here

IMPORTANT SAFETY INFORMATION FOR THE COMBINED ORAL CONTRACEPTIVES (COCS)

Chateal EQ® (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Aubra EQ® (levonorgestrel and ethinyl estradiol tablets, USP 0.1 mg/0.02 mg), Tarina Fe 1/20 EQ® (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, 1 mg/20 mcg and 75 mg), Cyred EQ® (desogestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.25/0.035 mg), Tri-VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg), and Tri-VyLibra®Lo (norgestimate and ethinyl estradiol tablets, USP 0.18mg/0.025mg, 0.215mg/0.025mg, 0.25mg/0.025mg).

Indication and Usage of Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ, VyLibra and Tri-VyLibra Lo

Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ, VyLibra and Tri-VyLibra Lo are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Tri-VyLibra is indicated for use by women to prevent pregnancy and is also indicated to treat moderate acne in women 15 years of age and older who also wish to use oral contraception.

IMPORTANT SAFETY INFORMATION about Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ, VyLibra, Tri-VyLibra and Tri-VyLibra Lo including Boxed Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ, VyLibra, Tri-VyLibra and Tri-VyLibra Lo should not be used by women who are over 35 years of age who smoke.

Consult the Package Insert for Complete Prescribing Information for each combined oral contraceptive product

Contraindications

Do not prescribe combined oral contraceptives to women who currently have the following conditions:

  • A high risk of arterial or venous thrombotic disease including women who are known to smoke if over age 35, have a current or past history of deep vein thrombosis, pulmonary embolism, thrombophlebitis, thrombophilic conditions or thromboembolic disorders, have cerebrovascular or coronary artery disease (current or history), have valvular heart disease with complications, have persistent blood pressure values of greater than or equal to 160 mm Hg systolic or greater than or equal to 100 mm Hg diastolic, have headache with focal neurologic symptoms, or have diabetes with vascular involvement
  • Major surgery with prolonged immobilization
  • Known or suspected carcinoma of breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Acute or chronic hepatocellular disease with abnormal liver function, hepatic adenomas or carcinoma
  • Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
  • Known or suspected pregnancy
  • Hypersensitivity to any of the components of the oral contraceptive pills
  • Are receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
WARNINGS AND PRECAUTIONS
  • Thrombotic and other vascular events—Stop combined oral contraceptives if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (evaluate for retinal thrombosis immediately). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors
  • Carcinoma of the breast, endometrium, or estrogen-sensitive neoplasias—Women with current or past history of these diseases should not use COCs
  • Liver Disease—Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (>8 years use) are associated with COC use. Do not use in women receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
  • High Blood pressure—Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use COCs
  • Other warnings and precautions include gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests
ADVERSE REACTIONS

The most serious reactions are discussed in detail in the full product labeling and include serious cardiovascular events and smoking, vascular events, and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference: Chateal EQ®, Aubra EQ®, Tarina Fe 1/20 EQ®, Cyred EQ®, VyLibra®, Tri-VyLibra® and Tri-VyLibra® Lo prescribing information. Charleston, SC: Afaxys Pharma, LLC; 2017, 2018.

Please see full Prescribing Information for Chateal EQ® here.
Please see full Prescribing Information for Aubra EQ® here.
Please see full Prescribing Information for Tarina Fe 1/20 EQ® here.
Please see full Prescribing Information for Cyred EQ® here.
Please see full Prescribing Information for VyLibra® here.
Please see full Prescribing Information for Tri-VyLibra® here.
Please see full Prescribing Information for Tri-VyLibra® Lo here.


IMPORTANT SAFETY INFORMATION FOR JASMIEL™ (DROSPIRENONE AND ETHINYL TABLETS, USP 3.0 MG/0.02 MG)

INDICATION AND USAGE

Jasmiel is an estrogen/progestin combined oral contraceptive indicated for use by women to:

  • Prevent pregnancy
  • Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception
  • Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control
Consult the Package Insert for Complete Prescribing Information

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

CONTRAINDICATIONS
  • Renal impairment
  • Adrenal insufficiency
  • A high risk of arterial or venous thrombotic diseases
  • Undiagnosed abnormal uterine bleeding
  • Breast cancer of other estrogen- or progestin-sensitive cancer
  • Liver tumors or liver disease
  • Pregnancy
  • Co-administration with hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir
WARNINGS AND PRECAUTIONS
  • Vascular risks—Stop Jasmiel if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating Jasmiel in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.
  • Hyperkalemia—DRSP has anti-mineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.
  • Liver disease—Discontinue Jasmiel if jaundice occurs.
  • High blood pressure—Do not prescribe Jasmiel for women with uncontrolled hypertension or hypertension with vascular disease.
  • Carbohydrate and lipid metabolic effects—Monitor prediabetic and diabetic women taking Jasmiel. Consider an alternative contraceptive method for women in uncontrolled dyslipidemia.
  • Headache—Evaluate significant change in headlines and discontinue Jasmiel if indicated.
  • Uterine bleeding—Evaluate irregular bleeding or amenorrhea.
ADVERSE REACTIONS

The most frequent adverse reactions (≥2%) in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%), and mood changes (2.2%).
The most frequent adverse reactions (≥2%) in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).

Patients should be counseled that Jasmiel does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference:
Data on file. IMS Data; 2017.
Jasmiel™ [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; September 2018.

Please see full Prescribing Information for Jasmiel here.


IMPORTANT SAFETY INFORMATION FOR TARINA® 24 Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1.0 mg/0.02 mg and 75 mg)

INDICATION

Tarina 24 Fe is a progestin/estrogen combined oral contraceptive indicated for use by women to prevent pregnancy. The efficacy of Tarina 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m2 has not been evaluated.

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

Consult the Package Insert for Complete Prescribing Information

CONTRAINDICATIONS

Do not prescribe Tarina 24 Fe to women who currently have the following conditions:

  • A high risk of arterial or venous thrombotic disease
  • Breast cancer or other estrogen- or progestin-sensitive cancer
  • Undiagnosed abnormal uterine bleeding
  • Liver tumors or liver disease
  • Pregnancy
  • Are receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
WARNINGS AND PRECAUTIONS
  • Thrombotic disorders and other vascular problems—Stop Tarina 24 Fe if a thrombotic event occurs. Stop at least 4 weeks before and 2 weeks after major surgery. Start no earlier than 4 weeks after delivery in women who are not breastfeeding.
  • Liver disease—Discontinue Tarina 24 Fe if jaundice occurs.
  • High blood pressure—If used in women with wellcontrolled hypertension, monitor blood pressure and stop Tarina 24 Fe if blood pressure rises significantly.
  • Carbohydrate and lipid metabolic effects—Monitor prediabetic and diabetic women taking Tarina 24 Fe. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache—Evaluate significant change in headaches and discontinue Tarina 24 Fe if indicated.
  • Bleeding irregularities and amenorrhea—Evaluate irregular bleeding or amenorrhea.
ADVERSE REACTIONS

The most common adverse reactions reported (greater than or equal to 2%) include headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain

Patients should be counseled that Tarina 24 Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference:
Data on file. IMS Data; 2017.
Tarina® 24 Fe [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2018.

Please see full Prescribing Information for Tarina® 24 Fe here.


Important Safety Information for Tulana (norethindrone tablets, USP 0.35 mg)

INDICATION
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

CONTRAINDICATIONS
Include known or suspected pregnancy, known or suspected carcinoma of the breast, undiagnosed abnormal genital bleeding, benign or malignant liver tumors or active liver disease, and hypersensitivity to any components of the pills.

WARNINGS

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke

OTHER WARNINGS Include ectopic pregnancy considerations, delayed follicular atresia/ovarian cysts, irregular genital bleeding, carcinoma of the breast and reproductive organs, and hepatic neoplasias.

PRECAUTIONS
Include carbohydrate and lipid metabolism, drug interactions, interactions with laboratory tests, pregnancy, nursing mothers, pediatric use, fertility following discontinuation and headache.

ADVERSE REACTIONS
Reported with progestin-only pills include menstrual irregularities, headache, breast tenderness, nausea, and dizziness. Androgenic side effects such as acne, hirsuitism, and weight gain occur rarely.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference:
Tulana prescribing information. Charleston, SC: Afaxys Pharma, LLC; March 2018.

Please see full Prescribing Information for Tulana here.


ella® (ulipristal acetate 30 mg tablet) Important Safety Information

ella is a progesterone agonist/antagonist emergency contraceptive indicated for the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not indicated for routine use as a contraceptive.
The most common side effects of ella (ulipristal acetate) tablets include headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%). ella is contraindicated in women with a known or suspected pregnancy, and should not replace a regular method of contraception. ella is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy. ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. A rapid return of fertility is likely following treatment with ella, therefore, a reliable barrier method of contraception should be used with subsequent acts of intercourse in that same menstrual cycle. Because ella and the progestin component of hormonal contraceptives both bind to the progesterone receptor, using them together could reduce their contraceptive effectiveness. After using ella, if a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake of ella. Repeated use of ella within the same menstrual cycle is not recommended. Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella. ella does not protect against STI/HIV.

Reference: ella® prescribing information. Charleston, SC: Afaxys Pharma, LLC; May 2018.

Please see full Prescribing Information for ella® here.


EContra One-Step Product Information

Usage
EContra One-Step (Levonorgestrel 1.5 mg tablet) is a progestin-only emergency contraceptive pill indicated for use in women to reduce the chance of pregnancy after unprotected sex (if contraceptive failed or birth control not used). EContra One-Step is not intended to be used in place of routine birth control.

Who Should Not Use EContra One-Step

  • Women who are known to be pregnant as it will not work. However, EContra One-Step will not harm an existing pregnancy
  • Women known to be allergic to Levonorgestrel

Women should ask a doctor or pharmacist before using EContra One-Step if taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

Side effects may include menstrual changes, abdominal pain, nausea, vomiting, tiredness, headache, dizziness, or breast pain.

Reference: EContra One-Step product information. Charleston, SC, Afaxys Pharma, LLC; November 2017.

Please see full Product Information for EContra One-Step here.