vagifem

Generic: estradiol

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vagifem
Generic Name estradiol
Labeler novo nordisk
Dosage Form INSERT
Routes
VAGINAL
Active Ingredients

estradiol 10 ug/1

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-5176
Product ID 0169-5176_9564f4b5-dbf2-429a-b058-f240e296cec9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020908
Listing Expiration 2026-12-31
Marketing Start 2010-01-11

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 01695176
Hyphenated Format 0169-5176

Supplemental Identifiers

RxCUI
884707 884709
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 vagifem (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA020908 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/1
source: ndc
Packaging
  • 8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR
  • 18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR
  • 6 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATOR
source: ndc

Packages (3)

0169-5176-03 8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR 0169-5176-04 18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR 0169-5176-99 6 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATOR

Ingredients (1)

estradiol (10 ug/1)

Linked Drug Pages (1)

Vagifem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "9564f4b5-dbf2-429a-b058-f240e296cec9", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["884707", "884709"], "spl_set_id": ["e5ad3cf6-dd96-4e64-af21-c1eee38d0b88"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 APPLICATOR in 1 CARTON (0169-5176-03)  / 1 INSERT in 1 APPLICATOR", "package_ndc": "0169-5176-03", "marketing_start_date": "20100111"}, {"sample": false, "description": "18 APPLICATOR in 1 CARTON (0169-5176-04)  / 1 INSERT in 1 APPLICATOR", "package_ndc": "0169-5176-04", "marketing_start_date": "20100111"}, {"sample": false, "description": "6 APPLICATOR in 1 CARTON (0169-5176-99)  / 1 INSERT in 1 APPLICATOR", "package_ndc": "0169-5176-99", "marketing_start_date": "20100111"}], "brand_name": "Vagifem", "product_id": "0169-5176_9564f4b5-dbf2-429a-b058-f240e296cec9", "dosage_form": "INSERT", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0169-5176", "generic_name": "estradiol", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vagifem", "active_ingredients": [{"name": "ESTRADIOL", "strength": "10 ug/1"}], "application_number": "NDA020908", "marketing_category": "NDA", "marketing_start_date": "20100111", "listing_expiration_date": "20261231"}