estradiol

Generic: estradiol

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estradiol 1 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-022
Product ID 76420-022_ead12b79-385c-4dee-e053-2a95a90ac9da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040275
Listing Expiration 2026-12-31
Marketing Start 2017-04-10

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 76420022
Hyphenated Format 76420-022

Supplemental Identifiers

RxCUI
197657 197658 197659
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
  • 100 TABLET in 1 BOTTLE (76420-022-10)
source: ndc

Packages (1)

76420-022-10 100 TABLET in 1 BOTTLE (76420-022-10)

Ingredients (1)

estradiol (1 mg/1)

Linked Drug Pages (2)

ESTRADIOL ndc-match (0.9) ESTRADIOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ead12b79-385c-4dee-e053-2a95a90ac9da", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197657", "197658", "197659"], "spl_set_id": ["229b4ec5-d3c8-4406-9fc5-8f633c6447b8"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-022-10)", "package_ndc": "76420-022-10", "marketing_start_date": "20200929"}], "brand_name": "ESTRADIOL", "product_id": "76420-022_ead12b79-385c-4dee-e053-2a95a90ac9da", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "76420-022", "generic_name": "ESTRADIOL", "labeler_name": "Asclemed USA, Inc.", "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": "20170410", "listing_expiration_date": "20261231"}