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United States · US · US:0245-0860_44ff0133-9823-f57e-e063-6294a90a5c73

Vandazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerUpsher-smith Laboratories, LLC
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0245086070
    1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
N021806
BX
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Metronidazole Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "140QMO216E",
    "rxcui": "6922",
    "inchikey": "VAOCPAMSLUNLGC-UHFFFAOYSA-N",
    "display_name": "METRONIDAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "27d71471-8f89-4a1e-8c55-020a58961454": {
      "match": "brand_token",
      "title": "VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "14",
      "published_date": "2025-12-04"
    }
  },
  "productid": "0245-0860_44ff0133-9823-f57e-e063-6294a90a5c73",
  "productndc": "0245-0860",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "021806",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "BX",
        "strength": "0.75%",
        "product_no": "001",
        "approval_date": "May 20, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METRONIDAZOLE",
  "shortage_reason": "Metronidazole Injection",
  "shortage_status": "current",
  "proprietary_name": "Vandazole",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA021806",
  "marketing_category": "NDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "20051004",
  "active_numerator_strength": "7.5"
}

Related drugs

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