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United States · US · US:61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84ad

Oravig

Orange BookUNIISPLATC G01AF04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGalt Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG01AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6182530314
    14 TABLET in 1 BOTTLE (61825-303-14)

Annotations

UNII (FDA Substance ID)
7NNO0D7S5M
MICONAZOLE
RxCUI 6932
Orange Book
N022404
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7NNO0D7S5M",
    "rxcui": "6932",
    "inchikey": "BYBLEWFAAKGYCD-UHFFFAOYSA-N",
    "display_name": "MICONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "BUCCAL",
  "spl_meta": {
    "dc2427ff-e566-4b48-b289-9e51c011250a": {
      "match": "brand_token",
      "title": "ORAVIG (MICONAZOLE) TABLET [GALT PHARMACEUTICALS, LLC]",
      "spl_version": "3",
      "published_date": "2026-01-09"
    }
  },
  "productid": "61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84ad",
  "productndc": "61825-303",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022404",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICONAZOLE",
  "proprietary_name": "Oravig",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022404",
  "marketing_category": "NDA",
  "nonproprietary_name": "Miconazole",
  "start_marketing_date": "20211231",
  "active_numerator_strength": "50"
}

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