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United States · US · US:0338-1055_7841a410-43a9-4c79-acee-b831b42da8a8

Metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338105548
    24 BAG in 1 CARTON (0338-1055-48) / 100 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
N018657
AP
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": "INTRAVENOUS",
  "spl_meta": {
    "74cf111a-9b83-4f93-b0e8-bc252d471d43": {
      "match": "brand_token",
      "title": "METRONIDAZOLE INJECTION, SOLUTION [GLAND PHARMA LIMITED]",
      "spl_version": "11",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0338-1055_7841a410-43a9-4c79-acee-b831b42da8a8",
  "productndc": "0338-1055",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018657",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "500MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METRONIDAZOLE",
  "shortage_reason": "Metronidazole Injection",
  "shortage_status": "current",
  "proprietary_name": "Metronidazole",
  "active_ingred_unit": "mg/100mL",
  "application_number": "NDA018657",
  "marketing_category": "NDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "19811224",
  "active_numerator_strength": "500"
}

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