estradiol

Generic: estradiol

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler teva pharmaceuticals usa, inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

estradiol .1 mg/g

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-3541
Product ID 0093-3541_691ab23f-2d05-4054-8de7-b3759a6edeb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086069
Listing Expiration 2026-12-31
Marketing Start 2018-01-02

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 00933541
Hyphenated Format 0093-3541

Supplemental Identifiers

RxCUI
310169
UPC
0300933541435
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 ANDA086069 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (0093-3541-43) / 42.5 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

0093-3541-43 1 TUBE, WITH APPLICATOR in 1 CARTON (0093-3541-43) / 42.5 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

estradiol (.1 mg/g)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "691ab23f-2d05-4054-8de7-b3759a6edeb6", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0300933541435"], "unii": ["4TI98Z838E"], "rxcui": ["310169"], "spl_set_id": ["c94738ff-dece-4fb6-bb44-4f8832a45f38"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (0093-3541-43)  / 42.5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "0093-3541-43", "marketing_start_date": "20180102"}], "brand_name": "Estradiol", "product_id": "0093-3541_691ab23f-2d05-4054-8de7-b3759a6edeb6", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0093-3541", "generic_name": "Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".1 mg/g"}], "application_number": "ANDA086069", "marketing_category": "ANDA", "marketing_start_date": "20180102", "listing_expiration_date": "20261231"}