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NDC 63629-8802-01 Estradiol 0.5 mg/1 Details
Estradiol 0.5 mg/1
Estradiol is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ESTRADIOL.
MedlinePlus Drug Summary
Estrogen is used to treat 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). Some brands of estrogen are also used to treat vaginal dryness, itching, or burning, or to prevent osteoporosis (a condition in which the bones become thin and weak and break easily) in women who are experiencing or have experienced menopause. However, women who need a medication only to treat vaginal dryness or only to prevent osteoporosis should consider a different treatment. Some brands of estrogen are also to relieve symptoms of low estrogen in young women who do not produce enough estrogen naturally. Some brands of estrogen are also used to relieve the symptoms of certain types of breast and prostate (a male reproductive gland) cancer. Estrogen is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
Related Packages: 63629-8802-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Estrogen
Product Information
| NDC | 63629-8802 |
|---|---|
| Product ID | 63629-8802_63fef87a-29dd-4bb7-9295-a7e48e3ecdec |
| Associated GPIs | 24000035000303 |
| GCN Sequence Number | 021411 |
| GCN Sequence Number Description | estradiol TABLET 0.5 MG ORAL |
| HIC3 | G1A |
| HIC3 Description | ESTROGENIC AGENTS |
| GCN | 10772 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | ESTRADIOL |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA040197 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63629-8802-01 (63629880201)
| NDC Package Code | 63629-8802-1 |
|---|---|
| Billing NDC | 63629880201 |
| Package | 100 TABLET in 1 BOTTLE (63629-8802-1) |
| Marketing Start Date | 2021-09-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |