estradiol

Generic: estradiol

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

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler amneal pharmaceuticals ny llc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

estradiol .05 mg/d

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1295
Product ID 69238-1295_257bffaf-8bc9-4557-a1e3-bab40bee2fb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211396
Listing Expiration 2026-12-31
Marketing Start 2020-09-30

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 692381295
Hyphenated Format 69238-1295

Supplemental Identifiers

RxCUI
241946 242891 242892 248478 1149632
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 ANDA211396 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 CARTON (69238-1295-7) / 1 d in 1 POUCH (69238-1295-1)
source: ndc

Packages (1)

69238-1295-7 8 POUCH in 1 CARTON (69238-1295-7) / 1 d in 1 POUCH (69238-1295-1)

Ingredients (1)

estradiol (.05 mg/d)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "257bffaf-8bc9-4557-a1e3-bab40bee2fb7", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["241946", "242891", "242892", "248478", "1149632"], "spl_set_id": ["d4259bb8-91f8-4587-8ceb-35d44145aec0"], "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": "8 POUCH in 1 CARTON (69238-1295-7)  / 1 d in 1 POUCH (69238-1295-1)", "package_ndc": "69238-1295-7", "marketing_start_date": "20200930"}], "brand_name": "Estradiol", "product_id": "69238-1295_257bffaf-8bc9-4557-a1e3-bab40bee2fb7", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "69238-1295", "generic_name": "Estradiol", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".05 mg/d"}], "application_number": "ANDA211396", "marketing_category": "ANDA", "marketing_start_date": "20200930", "listing_expiration_date": "20261231"}