Source: FDA, National Drug Code (US) Revision Year: 2019
PROMETRIUM (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (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 is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. PROMETRIUM Capsules are available in multiple strengths to afford dosage flexibility for optimum management. PROMETRIUM Capsules contain 100 mg or 200 mg micronized progesterone.
The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10.
The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.
| How Supplied |
|---|
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PROMETRIUM (progesterone, USP) Capsules 100 mg are round, peach-colored capsules branded with black imprint “SV”. NDC 69543-372-10 (Bottle of 100) PROMETRIUM (progesterone, USP) Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint "SV2." NDC 69543-373-10 (Bottle of 100) Manufactured by: Catalent Pharma Solutions, St. Petersburg, FL 33716 Marketed by: Virtus Pharmaceuticals, LLC., Newtown, PA 18940 |
| Drug | Countries | |
|---|---|---|
| PROMETRIUM | Canada, Italy, United States |
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