elestrin

Generic: estradiol

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name elestrin
Generic Name estradiol
Labeler viatris specialty llc
Dosage Form GEL, METERED
Routes
TOPICAL
Active Ingredients

estradiol .52 mg/.87g

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-4801
Product ID 0037-4801_1246f55c-8c45-4fbd-af2c-91bb74e8310b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021813
Listing Expiration 2026-12-31
Marketing Start 2014-06-02

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 00374801
Hyphenated Format 0037-4801

Supplemental Identifiers

RxCUI
226597 706467
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 elestrin (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA021813 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .52 mg/.87g
source: ndc
Packaging
  • 2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)
source: ndc

Packages (1)

0037-4801-70 2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)

Ingredients (1)

estradiol (.52 mg/.87g)

Linked Drug Pages (1)

ELESTRIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1246f55c-8c45-4fbd-af2c-91bb74e8310b", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["226597", "706467"], "spl_set_id": ["eff2dea1-f117-11e3-ac10-0800200c9a66"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PUMP in 1 CARTON (0037-4801-70)  / 35 g in 1 BOTTLE, PUMP (0037-4801-35)", "package_ndc": "0037-4801-70", "marketing_start_date": "20181105"}], "brand_name": "ELESTRIN", "product_id": "0037-4801_1246f55c-8c45-4fbd-af2c-91bb74e8310b", "dosage_form": "GEL, METERED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0037-4801", "generic_name": "ESTRADIOL", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELESTRIN", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".52 mg/.87g"}], "application_number": "NDA021813", "marketing_category": "NDA", "marketing_start_date": "20140602", "listing_expiration_date": "20261231"}