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NDC 00378-8770-35 Estradiol 0.1 mg/g Details
Estradiol 0.1 mg/g
Estradiol is a VAGINAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is ESTRADIOL.
MedlinePlus Drug Summary
Estradiol topical gel and emulsion (lotion type mixture) are used to treat and prevent hot flushes (hot flashes; sudden strong feelings of heat and sweating) in women who are experiencing menopause (change of life; the end of monthly menstrual periods). Estradiol topical gel is also used to treat vaginal dryness, itching, and burning in women who are experiencing menopause. However, women whose only bothersome symptoms are vaginal burning, itching, and dryness may benefit more from a medication that is applied topically to the vagina. Estradiol is in a class of medications called estrogen hormones. It works by replacing estrogen that is normally produced by the body.
Related Packages: 00378-8770-35Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Estradiol Topical
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: 00378-8770-35Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Estrogen Vaginal
Product Information
| NDC | 00378-8770 |
|---|---|
| Product ID | 0378-8770_982b2667-6b0f-4287-b72c-4616754ec37a |
| Associated GPIs | 55350020003705 |
| GCN Sequence Number | 007011 |
| GCN Sequence Number Description | estradiol CREAM/APPL 0.01 % VAGINAL |
| HIC3 | Q4K |
| HIC3 Description | VAGINAL ESTROGEN PREPARATIONS |
| GCN | 67170 |
| HICL Sequence Number | 001421 |
| HICL Sequence Number Description | ESTRADIOL |
| Brand/Generic | Generic |
| Proprietary Name | Estradiol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Estradiol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | VAGINAL |
| Active Ingredient Strength | 0.1 |
| Active Ingredient Units | mg/g |
| Substance Name | ESTRADIOL |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208788 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-8770-35 (00378877035)
| NDC Package Code | 0378-8770-35 |
|---|---|
| Billing NDC | 00378877035 |
| Package | 1 TUBE in 1 CARTON (0378-8770-35) / 42.5 g in 1 TUBE |
| Marketing Start Date | 2017-12-29 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.54461 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | ESTRADIOL 0.01% CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |