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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

  • ndc11
    0169517603
    8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR
  • ndc11
    0169517604
    18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR
  • ndc11
    0169517699
    6 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        "strength": "25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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

Other records sharing ATC code G03CA03.

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