estradiol

Generic: estradiol

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estradiol .5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8802
Product ID 63629-8802_68f6bbcc-3416-4100-9f6d-5e33e4a37ec9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040197
Listing Expiration 2026-12-31
Marketing Start 1997-10-28

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298802
Hyphenated Format 63629-8802

Supplemental Identifiers

RxCUI
197657
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name estradiol (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA040197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63629-8802-1)
source: ndc

Packages (1)

63629-8802-1 100 TABLET in 1 BOTTLE (63629-8802-1)

Ingredients (1)

estradiol (.5 mg/1)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "68f6bbcc-3416-4100-9f6d-5e33e4a37ec9", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197657"], "spl_set_id": ["414b846a-d6d9-4e8a-9632-12e296fc13c3"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-8802-1)", "package_ndc": "63629-8802-1", "marketing_start_date": "20240404"}], "brand_name": "Estradiol", "product_id": "63629-8802_68f6bbcc-3416-4100-9f6d-5e33e4a37ec9", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "63629-8802", "generic_name": "Estradiol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/1"}], "application_number": "ANDA040197", "marketing_category": "ANDA", "marketing_start_date": "19971028", "listing_expiration_date": "20261231"}