estradiol

Generic: estradiol

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

estradiol 1 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-502
Product ID 72189-502_2c4e4735-85f4-83d7-e063-6394a90adcc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040275
Listing Expiration 2026-12-31
Marketing Start 2023-07-27

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 72189502
Hyphenated Format 72189-502

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 ANDA040275 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72189-502-60)
  • 90 TABLET in 1 BOTTLE (72189-502-90)
source: ndc

Packages (2)

72189-502-60 60 TABLET in 1 BOTTLE (72189-502-60) 72189-502-90 90 TABLET in 1 BOTTLE (72189-502-90)

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": "2c4e4735-85f4-83d7-e063-6394a90adcc0", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197658"], "spl_set_id": ["01789bad-4be4-ae22-e063-6294a90af392"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-502-60)", "package_ndc": "72189-502-60", "marketing_start_date": "20230727"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-502-90)", "package_ndc": "72189-502-90", "marketing_start_date": "20230727"}], "brand_name": "Estradiol", "product_id": "72189-502_2c4e4735-85f4-83d7-e063-6394a90adcc0", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "72189-502", "generic_name": "Estradiol", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}], "application_number": "ANDA040275", "marketing_category": "ANDA", "marketing_start_date": "20230727", "listing_expiration_date": "20261231"}