estrace

Generic: estradiol

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estrace
Generic Name estradiol
Labeler a-s medication solutions
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

estradiol .1 mg/g

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-2321
Product ID 50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87
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 500902321
Hyphenated Format 50090-2321

Supplemental Identifiers

RxCUI
310169 890918
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

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
  • 1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE
source: ndc

Packages (1)

50090-2321-0 1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE

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": "d0bdce5c-be19-4bfa-bc55-9682f516ea87", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["310169", "890918"], "spl_set_id": ["da52a602-f2a2-4382-be07-30351c58cc4b"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (50090-2321-0)  / 42.5 g in 1 TUBE", "package_ndc": "50090-2321-0", "marketing_start_date": "20160302"}], "brand_name": "ESTRACE", "product_id": "50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "50090-2321", "generic_name": "estradiol", "labeler_name": "A-S Medication Solutions", "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"}