estradiol vaginal inserts (59651-439)

Drug Facts

Product Profile

Brand Name estradiol vaginal inserts

Generic Name estradiol

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

VAGINAL

Active Ingredients

estradiol hemihydrate 10 ug/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-439

Product ID 59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216550

Listing Expiration 2026-12-31

Marketing Start 2024-08-02

Pharmacologic Class

Classes

estradiol congeners [cs] estrogen receptor agonists [moa] estrogen [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651439

Hyphenated Format 59651-439

Supplemental Identifiers

RxCUI

884707

UNII

CXY7B3Q98Z

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 vaginal inserts (source: ndc)

Generic Name estradiol (source: ndc)

Application Number ANDA216550 (source: ndc)

Routes

VAGINAL

source: ndc

Resolved Composition

Strengths

10 ug/1

source: ndc

Packaging

8 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATOR
18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR

source: ndc

Packages (2)

59651-439-08 8 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATOR 59651-439-18 18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR

Ingredients (1)

estradiol hemihydrate (10 ug/1)

Linked Drug Pages (1)

ESTRADIOL VAGINAL INSERTS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["VAGINAL"], "spl_id": "2df3b31e-32a6-49cd-a636-5b7779a5ed0c", "openfda": {"unii": ["CXY7B3Q98Z"], "rxcui": ["884707"], "spl_set_id": ["6247e329-e20e-4ea5-9cc1-b593bd494577"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 APPLICATOR in 1 CARTON (59651-439-08)  / 1 TABLET, FILM COATED in 1 APPLICATOR", "package_ndc": "59651-439-08", "marketing_start_date": "20240802"}, {"sample": false, "description": "18 APPLICATOR in 1 CARTON (59651-439-18)  / 1 TABLET, FILM COATED in 1 APPLICATOR", "package_ndc": "59651-439-18", "marketing_start_date": "20240802"}], "brand_name": "ESTRADIOL VAGINAL INSERTS", "product_id": "59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "59651-439", "generic_name": "Estradiol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTRADIOL VAGINAL INSERTS", "active_ingredients": [{"name": "ESTRADIOL HEMIHYDRATE", "strength": "10 ug/1"}], "application_number": "ANDA216550", "marketing_category": "ANDA", "marketing_start_date": "20240802", "listing_expiration_date": "20261231"}