estradiol

Generic: estradiol

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler ani pharmaceuticals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

estradiol 1.25 mg/1.25g

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-534
Product ID 70954-534_98963341-a7e0-4b8d-bb56-be1820611090
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217610
Listing Expiration 2026-12-31
Marketing Start 2023-08-24

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 70954534
Hyphenated Format 70954-534

Supplemental Identifiers

RxCUI
2619677 2619679 2619681 2619683 2619685
UPC
0370954531104 0370954530107 0370954532101 0370954534105 0370954533108
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

Packaging Origin

Original Packager
true

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 ANDA217610 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1.25g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (70954-534-20) / 1.25 g in 1 PACKET (70954-534-10)
source: ndc

Packages (1)

70954-534-20 30 PACKET in 1 CARTON (70954-534-20) / 1.25 g in 1 PACKET (70954-534-10)

Ingredients (1)

estradiol (1.25 mg/1.25g)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "98963341-a7e0-4b8d-bb56-be1820611090", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0370954531104", "0370954530107", "0370954532101", "0370954534105", "0370954533108"], "unii": ["4TI98Z838E"], "rxcui": ["2619677", "2619679", "2619681", "2619683", "2619685"], "spl_set_id": ["ff28c624-906d-459c-8b8c-27cb1a664e12"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (70954-534-20)  / 1.25 g in 1 PACKET (70954-534-10)", "package_ndc": "70954-534-20", "marketing_start_date": "20230824"}], "brand_name": "Estradiol", "product_id": "70954-534_98963341-a7e0-4b8d-bb56-be1820611090", "dosage_form": "GEL", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "70954-534", "generic_name": "Estradiol", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1.25 mg/1.25g"}], "application_number": "ANDA217610", "marketing_category": "ANDA", "marketing_start_date": "20230824", "listing_expiration_date": "20261231"}