estradiol

Generic: estradiol

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estradiol .5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1568
Product ID 67046-1568_37c99db2-4680-0f78-e063-6394a90a8483
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217334
Listing Expiration 2026-12-31
Marketing Start 2025-06-17

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 670461568
Hyphenated Format 67046-1568

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 ANDA217334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1568-3)
source: ndc

Packages (1)

67046-1568-3 30 TABLET in 1 BLISTER PACK (67046-1568-3)

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": "37c99db2-4680-0f78-e063-6394a90a8483", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197657"], "spl_set_id": ["37c99e4d-fb0d-0e6e-e063-6394a90a69c8"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1568-3)", "package_ndc": "67046-1568-3", "marketing_start_date": "20250617"}], "brand_name": "Estradiol", "product_id": "67046-1568_37c99db2-4680-0f78-e063-6394a90a8483", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "67046-1568", "generic_name": "Estradiol", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/1"}], "application_number": "ANDA217334", "marketing_category": "ANDA", "marketing_start_date": "20250617", "listing_expiration_date": "20261231"}