estradiol vaginal inserts

Generic: estradiol

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

Drug Facts

Product Profile

Brand Name estradiol vaginal inserts
Generic Name estradiol
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
VAGINAL
Active Ingredients

estradiol 10 ug/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-711
Product ID 68462-711_732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210264
Listing Expiration 2026-12-31
Marketing Start 2018-09-17

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 68462711
Hyphenated Format 68462-711

Supplemental Identifiers

RxCUI
884707
UPC
0368462711880 0368462711712
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 vaginal inserts (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA210264 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/1
source: ndc
Packaging
  • 8 APPLICATOR in 1 CARTON (68462-711-71) / 1 TABLET, FILM COATED in 1 APPLICATOR
  • 18 APPLICATOR in 1 CARTON (68462-711-88) / 1 TABLET, FILM COATED in 1 APPLICATOR
source: ndc

Packages (2)

68462-711-71 8 APPLICATOR in 1 CARTON (68462-711-71) / 1 TABLET, FILM COATED in 1 APPLICATOR 68462-711-88 18 APPLICATOR in 1 CARTON (68462-711-88) / 1 TABLET, FILM COATED in 1 APPLICATOR

Ingredients (1)

estradiol (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": "732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0368462711880", "0368462711712"], "unii": ["4TI98Z838E"], "rxcui": ["884707"], "spl_set_id": ["86620f6c-fd02-40df-98d5-3048dcd92c37"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 APPLICATOR in 1 CARTON (68462-711-71)  / 1 TABLET, FILM COATED in 1 APPLICATOR", "package_ndc": "68462-711-71", "marketing_start_date": "20180917"}, {"sample": false, "description": "18 APPLICATOR in 1 CARTON (68462-711-88)  / 1 TABLET, FILM COATED in 1 APPLICATOR", "package_ndc": "68462-711-88", "marketing_start_date": "20180917"}], "brand_name": "ESTRADIOL VAGINAL INSERTS", "product_id": "68462-711_732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "68462-711", "generic_name": "estradiol", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTRADIOL VAGINAL INSERTS", "active_ingredients": [{"name": "ESTRADIOL", "strength": "10 ug/1"}], "application_number": "ANDA210264", "marketing_category": "ANDA", "marketing_start_date": "20180917", "listing_expiration_date": "20261231"}