Drug Catalog - Product Detail
Progesterone Micronized Cap 200 MG 100 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 59651-0153-01 | AUROBINDO PHARMA | 100 | 200MG | NA |
PACKAGE FILES
Generic Name
PROGESTERONE
Substance Name
PROGESTERONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA211285
Description
DESCRIPTION Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C 21 H 30 O 2 . Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, crystalline powder or colorless crystals practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, melting between 126º and 131ºC. The structural formula is: Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone USP. The inactive ingredients for progesterone capsules include: gelatin, glycerin, hypromellose, iron oxide black, lecithin, peanut oil, propylene glycol, titanium dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Progesterone Capsules 100 mg are white to off white, round shaped soft gelatin capsules imprinted with “P1” using black ink and containing white to off white suspension. Bottles of 100 NDC 59651-152-01 Progesterone Capsules 200 mg are white to off white, oval shaped soft gelatin capsules imprinted with “P2” using black ink and containing white to off white suspension. Bottles of 100 NDC 59651-153-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Patient Information is available at: www.aurobindousa.com/product-medication-guides Keep out of reach of children. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032 India
Indications & Usage
INDICATIONS AND USAGE Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
Dosage and Administration
DOSAGE AND ADMINISTRATION Prevention of Endometrial Hyperplasia Progesterone capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea Progesterone capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing progesterone capsules. For these women, progesterone capsules should be taken with a glass of water while in the standing position.