estradiol

Generic: estradiol

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estradiol 1 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-876
Product ID 60687-876_34298d94-75d4-458c-e063-6294a90af929
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040197
Listing Expiration 2026-12-31
Marketing Start 2025-05-02

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 60687876
Hyphenated Format 60687-876

Supplemental Identifiers

RxCUI
197658
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
  • 1 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (60687-876-65) / 1 TABLET in 1 BLISTER PACK (60687-876-11)
source: ndc

Packages (1)

60687-876-65 50 BLISTER PACK in 1 CARTON (60687-876-65) / 1 TABLET in 1 BLISTER PACK (60687-876-11)

Ingredients (1)

estradiol (1 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": "34298d94-75d4-458c-e063-6294a90af929", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197658"], "spl_set_id": ["265a1ee1-f314-4324-a2e1-0120a9a00a20"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (60687-876-65)  / 1 TABLET in 1 BLISTER PACK (60687-876-11)", "package_ndc": "60687-876-65", "marketing_start_date": "20250502"}], "brand_name": "Estradiol", "product_id": "60687-876_34298d94-75d4-458c-e063-6294a90af929", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "60687-876", "generic_name": "Estradiol", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}], "application_number": "ANDA040197", "marketing_category": "ANDA", "marketing_start_date": "20250502", "listing_expiration_date": "20261231"}