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United States · US · US:0169-5176_9564f4b5-dbf2-429a-b058-f240e296cec9
Vagifem
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovo Nordisk
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1101695176038 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR
- ndc11016951760418 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR
- ndc1101695176996 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N020908
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4TI98Z838E",
"rxcui": "4083",
"inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
"display_name": "ESTRADIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"spl_meta": {
"e5ad3cf6-dd96-4e64-af21-c1eee38d0b88": {
"match": "brand_token",
"title": "VAGIFEM (ESTRADIOL) INSERT [NOVO NORDISK]",
"spl_version": "22",
"published_date": "2025-02-12"
}
},
"productid": "0169-5176_9564f4b5-dbf2-429a-b058-f240e296cec9",
"productndc": "0169-5176",
"dosage_form": "INSERT",
"orange_book": {
"appl_no": "020908",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Mar 26, 1999"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MCG",
"product_no": "002",
"approval_date": "Nov 25, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Vagifem",
"active_ingred_unit": "ug/1",
"application_number": "NDA020908",
"marketing_category": "NDA",
"nonproprietary_name": "estradiol",
"start_marketing_date": "20100111",
"active_numerator_strength": "10"
}Related drugs
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