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NDC 00046-0872-04 Premarin 0.625 mg/g Details
Premarin 0.625 mg/g
Premarin is a VAGINAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. The primary component is ESTROGENS, CONJUGATED.
MedlinePlus Drug Summary
Vaginal estrogen is used to treat vaginal dryness, itching, and burning; painful or difficult urination; and sudden need to urinate immediately in women who are experiencing or have experienced menopause (change of life; the end of monthly menstrual periods). Femring® brand vaginal ring is also used to treat hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing menopause. Premarin® brand vaginal cream is also used to treat kraurosis vulvae (a condition that may cause vaginal dryness and discomfort in women or girls of any age). Imvexxy® brand vaginal inserts are used for the treatment of dyspareunia (difficult or painful sexual intercourse) in menopausal women. Vaginal estrogen is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
Related Packages: 00046-0872-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Estrogen Vaginal
Product Information
| NDC | 00046-0872 |
|---|---|
| Product ID | 0046-0872_5a5b8cbf-a567-4438-bef4-a149a404e848 |
| Associated GPIs | 55350025003710 |
| GCN Sequence Number | 007013 |
| GCN Sequence Number Description | estrogens, conjugated CREAM/APPL 0.625 MG/G VAGINAL |
| HIC3 | Q4K |
| HIC3 Description | VAGINAL ESTROGEN PREPARATIONS |
| GCN | 28410 |
| HICL Sequence Number | 001424 |
| HICL Sequence Number Description | ESTROGENS, CONJUGATED |
| Brand/Generic | Brand |
| Proprietary Name | Premarin |
| Proprietary Name Suffix | Vaginal |
| Non-Proprietary Name | conjugated estrogens |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | VAGINAL |
| Active Ingredient Strength | 0.625 |
| Active Ingredient Units | mg/g |
| Substance Name | ESTROGENS, CONJUGATED |
| Labeler Name | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
| Pharmaceutical Class | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020216 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00046-0872-04 (00046087204)
| NDC Package Code | 0046-0872-04 |
|---|---|
| Billing NDC | 00046087204 |
| Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04) / 4 g in 1 TUBE, WITH APPLICATOR |
| Marketing Start Date | 1978-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |