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NDC 70954-0530-20 Estradiol 0.5 mg/.5g Details
Estradiol 0.5 mg/.5g
Estradiol is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ANI Pharmaceuticals, Inc.. The primary component is ESTRADIOL.
MedlinePlus Drug Summary
Estradiol topical gel and spray 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: 70954-0530-20Last Updated: 05/12/2024
MedLinePlus Full Drug Details: Estradiol Topical
Product Information
| NDC | 70954-0530 |
|---|---|
| Product ID | 70954-530_ff28c624-906d-459c-8b8c-27cb1a664e12 |
| Associated GPIs | |
| GCN Sequence Number | 060493 |
| GCN Sequence Number Description | estradiol GEL PACKET 0.5MG/0.5G TRANSDERM |
| HIC3 | G1A |
| HIC3 Description | ESTROGENIC AGENTS |
| GCN | 26659 |
| 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 | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/.5g |
| Substance Name | ESTRADIOL |
| Labeler Name | ANI Pharmaceuticals, Inc. |
| Pharmaceutical Class | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA217610 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70954-0530-20 (70954053020)
| NDC Package Code | 70954-530-20 |
|---|---|
| Billing NDC | 70954053020 |
| Package | 30 PACKET in 1 CARTON (70954-530-20) / .5 g in 1 PACKET (70954-530-10) |
| Marketing Start Date | 2023-08-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 3.36973 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | ESTRADIOL 0.1% (0.5 MG) GEL PKT |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |