estradiol

Generic: estradiol transdermal

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol transdermal
Labeler amneal pharmaceuticals ny llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

estradiol 1.25 mg/1.25g

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2448
Product ID 69238-2448_cebb61d3-34b7-44a7-aae7-d23e21651713
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216055
Listing Expiration 2027-12-31
Marketing Start 2024-07-15

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 692382448
Hyphenated Format 69238-2448

Supplemental Identifiers

RxCUI
2619677 2619679 2619681 2619683 2619685
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 transdermal (source: ndc)
Application Number ANDA216055 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1.25g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (69238-2448-3) / 1.25 g in 1 PACKET (69238-2448-1)
source: ndc

Packages (1)

69238-2448-3 30 PACKET in 1 CARTON (69238-2448-3) / 1.25 g in 1 PACKET (69238-2448-1)

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": "cebb61d3-34b7-44a7-aae7-d23e21651713", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["2619677", "2619679", "2619681", "2619683", "2619685"], "spl_set_id": ["9669a0e3-27e2-4f6c-961c-7a67e9f84cc8"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (69238-2448-3)  / 1.25 g in 1 PACKET (69238-2448-1)", "package_ndc": "69238-2448-3", "marketing_start_date": "20240715"}], "brand_name": "Estradiol", "product_id": "69238-2448_cebb61d3-34b7-44a7-aae7-d23e21651713", "dosage_form": "GEL", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "69238-2448", "generic_name": "Estradiol Transdermal", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1.25 mg/1.25g"}], "application_number": "ANDA216055", "marketing_category": "ANDA", "marketing_start_date": "20240715", "listing_expiration_date": "20271231"}