estradiol

Generic: estradiol

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler amneal pharmaceuticals of new york llc
Dosage Form INSERT
Routes
VAGINAL
Active Ingredients

estradiol 10 ug/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-226
Product ID 53746-226_eb2cbf77-ea3e-4604-9271-cd2228059e30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205256
Listing Expiration 2026-12-31
Marketing Start 2015-06-07

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 53746226
Hyphenated Format 53746-226

Supplemental Identifiers

RxCUI
884707
UPC
0353746226211
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 ANDA205256 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/1
source: ndc
Packaging
  • 8 APPLICATOR in 1 CARTON (53746-226-21) / 1 INSERT in 1 APPLICATOR
  • 18 APPLICATOR in 1 CARTON (53746-226-23) / 1 INSERT in 1 APPLICATOR
source: ndc

Packages (2)

53746-226-21 8 APPLICATOR in 1 CARTON (53746-226-21) / 1 INSERT in 1 APPLICATOR 53746-226-23 18 APPLICATOR in 1 CARTON (53746-226-23) / 1 INSERT in 1 APPLICATOR

Ingredients (1)

estradiol (10 ug/1)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "eb2cbf77-ea3e-4604-9271-cd2228059e30", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0353746226211"], "unii": ["4TI98Z838E"], "rxcui": ["884707"], "spl_set_id": ["094830ee-1b1c-4cf7-8a39-427dfd56f9c9"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 APPLICATOR in 1 CARTON (53746-226-21)  / 1 INSERT in 1 APPLICATOR", "package_ndc": "53746-226-21", "marketing_start_date": "20150607"}, {"sample": false, "description": "18 APPLICATOR in 1 CARTON (53746-226-23)  / 1 INSERT in 1 APPLICATOR", "package_ndc": "53746-226-23", "marketing_start_date": "20150607"}], "brand_name": "Estradiol", "product_id": "53746-226_eb2cbf77-ea3e-4604-9271-cd2228059e30", "dosage_form": "INSERT", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "53746-226", "generic_name": "Estradiol", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "10 ug/1"}], "application_number": "ANDA205256", "marketing_category": "ANDA", "marketing_start_date": "20150607", "listing_expiration_date": "20261231"}