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

EContra® EZ

(Levonorgestrel) Tablet, 1.5 mg

distributor product number:

AmerisourceBergen: 10157388
ANDA: 501490
Cardinal: 5062591
Morris & Dickson: 603357
R&S Northeast: 011112
Seacoast Medical LLC: 500015
Smith Medical Partners LLC:
541-0949
View full Product Information here

ella

ella®

ulipristal acetate tablet 30 mg

distributor product number:

AmerisourceBergen: 10153832
ANDA: 50102091101
Cardinal: 5029780
McKesson: 3470556
Morris & Dickson: 602680
R&S Northeast: 091101
Seacoast Medical LLC: 500033
Smith Medical Partners LLC:
5264-882
View full Prescribing Information here

Aubra

Aubra®

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

distributor product number:

AmerisourceBergen: 10181189
ANDA: 327267
Cardinal: 5397765
Morris & Dickson: 072736
R&S Northeast: 0120030
Seacoast Medical LLC: 500037
Smith Medical Partners LLC:
5679659
View full Prescribing Information, including Boxed Warning, here

Chateal

Chateal®

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

distributor product number:

AmerisourceBergen: 10181273
ANDA: 327495
Cardinal: 5397757
Morris & Dickson: 072959
R&S Northeast: 013003
Seacoast Medical LLC: 500038
Smith Medical Partners LLC:
5679642
View full Prescribing Information, including Boxed Warning, here

Cyred

Cyred®

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

distributor product number:

AmerisourceBergen: 10157427
ANDA: 324354
Cardinal: 5134606
Morris & Dickson: 603506
R&S Northeast: 015403
Seacoast Medical LLC: 500035
Smith Medical Partners LLC:
550-6654
View full Prescribing Information, including Boxed Warning, here

Lyza

Lyza®

Norethindrone Tablets, USP 0.35 mg

distributor product number:

AmerisourceBergen: 10175039
ANDA: 326722
Cardinal: 5326251
Morris & Dickson: 902916
R&S Northeast: 0100030
Seacoast Medical LLC: 500036
Smith Medical Partners LLC:
565-4421
View full Prescribing Information here

Tarina

Tarina® Fe 1/20

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

distributor product number:

AmerisourceBergen: 10157426
ANDA: 323432
Cardinal: 5054275
Morris & Dickson: 603555
R&S Northeast: 012803
Seacoast Medical LLC: 500034
Smith Medical Partners LLC:
528-9129
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
Cardinal: 5423173
Morris & Dickson: 225870
R&S Northeast: 023513
Seacoast Medical LLC: 112406
Smith Medical Partners LLC:
570-7401
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
Cardinal: 5423181
Morris & Dickson: 225896
R&S Northeast: 023313
Seacoast Medical LLC: 112407
Smith Medical Partners LLC:
570-7294
View full Prescribing Information, including Boxed Warning, here

IMPORTANT SAFETY INFORMATION FOR THE COMBINED ORAL CONTRACEPTIVES (COCS)

Chateal® (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.03 mg), Aubra® (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg), Tarina® Fe 1/20 (Norethindrone Acetate and ethinyl estradiol tablets USP and Ferrous Fumarate Tablets, 1.0 mg/0.02 mg and 75 mg), Cyred® (desogestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg), VyLibra (Norgestimate and ethinyl estradiol tablets USP 0.25 mg/0.025 mg) and 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)

Indication and Usage of Chateal, Aubra, Tarina Fe 1/20, Cyred and VyLibra

Chateal, Aubra, Tarina Fe 1/20, Cyred and VyLibra 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.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination 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, Aubra, Tarina Fe 1/20, Cyred, VyLibra and Tri-VyLibra should not be used by women who are over 35 years of age who smoke.

Combined Oral Contraceptives: Consult the Package Insert for Complete Prescribing Information for each 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®, Aubra®, Tarina® Fe 1/20 and Cyred®, VyLibra and Tri-VyLibra [prescribing information]. Charleston, SC: Afaxys Pharma, LLC.; 2017.

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


Important Safety Information for Lyza® (Norethindrone 0.35 mg tablet USP)

INDICATIONS: 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 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: Lyza® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC.; June 2017.
Please see full Prescribing Information for Lyza® here.


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

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. ella is not recommended for use in breastfeeding women. 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.; June 2018.
Please see full Prescribing Information for ella® here.


EContra® EZ Product Information

Usage
EContra EZ (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 EZ is not intended to be used in place of routine birth control.

Who Should Not Use EContra EZ

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

Women should ask a doctor or pharmacist before using EContra EZ 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® EZ [product information]. Charleston, SC, Afaxys Pharma, LLC.; January 2018.

Please see full Product Information for EContra® EZ here.