Drug Catalog - Product Detail
PROGESTERONE 100MG CAP 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0807-10 | AMNEAL PHARMACEUTICALS | 100 | 100MG | CAPSULE |
PACKAGE FILES
Generic Name
PROGESTERONE
Substance Name
PROGESTERONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207724
Description
DESCRIPTION Progesterone capsules contain progesterone, USP for oral administration. Progesterone, USP has a molecular weight of 314.47 and a molecular formula of C 21 H 30 O 2 . Progesterone, USP (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is: Progesterone, USP 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 either 100 mg or 200 mg progesterone, USP. The inactive ingredients for progesterone capsules 100 mg and 200 mg include: arachis oil, D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, gelatin, glycerin, purified water, soy lecithin and titanium dioxide. chem structure
How Supplied
HOW SUPPLIED Progesterone capsules, 100 mg, are supplied as round, light orange soft gelatin capsules, printed with “A87”. They are available as follows: Bottles of 30: NDC 76420-058-30 (repackaged from NDC 65162-807-10) Bottles of 90: NDC 76420-058-90 (repackaged from NDC 65162-807-10) Bottles of 100: NDC 76420-058-10 (relabeled from NDC 65162-807-10) Progesterone capsules, 200 mg, are supplied as oval, light orange soft gelatin capsules, printed with “A80”. They are available as follows: Bottles of 30: NDC 76420-059-30 (repackaged from NDC 65162-808-10) Bottles of 90: NDC 76420-059-90 (repackaged from NDC 65162-808-10) Bottles of 100: NDC 76420-059-10 (relabeled from NDC 65162-808-10) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°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. Keep out of reach of children. Repackaged and Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501
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.