Drugplain

estrogens, conjugated .625 mg/1

estrogens, conjugated · TABLET, FILM COATED · Ingenus Pharmaceuticals, LLC

No Recall History
Plain English

estrogens, conjugated is a prescription tablet, film coated containing estrogens, conjugated at .625 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.

Key Facts

Brand Name
estrogens, conjugated
Generic Name
estrogens, conjugated
NDC Code (Product)
50742-389
Manufacturer
Ingenus Pharmaceuticals, LLC
Strength
.625 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Application #
ANDA214025
Drug Class
Estrogen Receptor Agonists [MoA]; Estrogen [EPC]
Marketing Start
10/16/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective150 reports
headache72 reports
fatigue70 reports
drug hypersensitivity68 reports
insomnia52 reports
pain51 reports
arthralgia47 reports
diarrhoea46 reports
dizziness45 reports
dysgeusia45 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Conjugated estrogens tablets is a mixture of estrogens indicated for: •Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. ( 1.1 ) •Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) •Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) •Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease ( 1.4 ) •Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) ( 1.5 ) •Prevention of Postmenopausal Osteoporosis ( 1.6 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. 1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure 1.4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease 1.5 Treatment o…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer [see Boxed Warning ]. A woman without a uterus does not need progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.16) ] . Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. Conjugated estrogens tablets may be taken without regard to meals. •Daily administration of 0.9 mg, and 1.25 mg ( 2.1 , 2.2 , 2.3 , 2.5 , 2.6 ) •Cyclic administration of 1.25 mg ( 2.1 , 2.2 , 2.3 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg conjugated estrogens tablets daily. Subsequent dosage adjustment may be made based upon the…

Contraindications

4 CONTRAINDICATIONS Conjugated estrogens tablets therapy is contraindicated in individuals with any of the following conditions: • Undiagnosed abnormal genital bleeding [see Warnings and Precautions ( 5.2 )] • Breast cancer or a history of breast cancer except in appropriately selected patients being treated for metastatic disease [see Warnings and Precautions ( 5.2 )] • Estrogen-dependent neoplasia [see Warnings and Precautions ( 5.2 )] • Active DVT, PE, or a history of these conditions [see Warnings and Precautions ( 5.1 )] • Active arterial thromboembolic disease (for example stroke and MI), or a history of these conditions [see Warnings and Precautions ( 5.1 )] • Known anaphylactic reaction or angioedema with conjugated estrogens tablets [see Warnings and Precautions ( 5.7 , 5.15 )] • Hepatic impairment or disease [see Warnings and Precautions ( 5.11 )] • Protein C, protein S or antithrombin deficiency, or other known thrombophilic disorders. •Undiagnosed abnormal genital bleeding ( 4 ) •Breast cancer or history of breast cancer except in appropriately selected patients being treated for metastatic diseases( 4 , 5.2 ) •Estrogen-dependent neoplasia ( 4 , 5.2 ) •Active DVT, PE, o…

Drug Interactions

7 DRUG INTERACTIONS Data from a single-dose drug-drug interaction study involving CE and MPA indicate that the pharmacokinetic disposition of both drugs is not altered when the drugs are coadministered. No other clinical drug-drug interaction studies have been conducted with CE. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism ( 7.1 ) 7.1 Metabolic Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John's Wort ( Hypericum perforatum ) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of estrogens and may result in side effects.

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in labeling: •Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.1) ] •Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.2) ] Most common adverse reactions (≥ 5 %) are: abdominal pain, asthenia, pain, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, and vaginitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC Toll-Free at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During the first year of a 2-year clinical trial with 2,333 postmenopausal women with a uterus between 40 and 65 years of age (88% Caucasian), 1,012 women were treated with CE , and 332 were treated with placebo. Table 1 summarizes treatment-related adverse rea…

Frequently Asked Questions

What is estrogens, conjugated used for?

estrogens, conjugated contains estrogens, conjugated. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is estrogens, conjugated a controlled substance?

estrogens, conjugated is not classified as a controlled substance by the DEA.

What is the generic name for estrogens, conjugated?

The generic name for estrogens, conjugated is estrogens, conjugated. There are 10 other brand versions of estrogens, conjugated.

What is the NDC code for estrogens, conjugated .625 mg/1?

The NDC (National Drug Code) for estrogens, conjugated .625 mg/1 is 50742-389, listed by Ingenus Pharmaceuticals, LLC.

Product NDC

50742-389

Package NDC

50742-389-01

Other Estrogens, Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)