estrace

Generic: estradiol

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

Drug Facts

Product Profile

Brand Name estrace
Generic Name estradiol
Labeler allergan, inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

estradiol .1 mg/g

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0430-3754
Product ID 0430-3754_4d3bc996-2273-415e-9fc1-158037932e15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086069
Listing Expiration 2026-12-31
Marketing Start 2001-07-01

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 04303754
Hyphenated Format 0430-3754

Supplemental Identifiers

RxCUI
310169 890918
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 estrace (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA086069 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

0430-3754-14 36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

estradiol (.1 mg/g)

Linked Drug Pages (1)

ESTRACE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "4d3bc996-2273-415e-9fc1-158037932e15", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["310169", "890918"], "spl_set_id": ["dfc41fcd-c5ba-4b25-b647-cf04d3988b3e"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "36 CARTON in 1 CASE (0430-3754-14)  / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "0430-3754-14", "marketing_start_date": "20010701"}], "brand_name": "ESTRACE", "product_id": "0430-3754_4d3bc996-2273-415e-9fc1-158037932e15", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0430-3754", "generic_name": "estradiol", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTRACE", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".1 mg/g"}], "application_number": "ANDA086069", "marketing_category": "ANDA", "marketing_start_date": "20010701", "listing_expiration_date": "20261231"}