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United States · US · US:68788-8674_57a2ffa7-f812-4e00-8787-260b705cd8bd

Metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6878886741
    14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-1)
  • ndc11
    6878886742
    21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-2)
  • ndc11
    6878886743
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-3)
  • ndc11
    6878886744
    28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-4)
  • ndc11
    6878886745
    56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-5)
  • ndc11
    6878886747
    42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8674-7)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A203458
ABAB
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": "ORAL",
  "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": "68788-8674_57a2ffa7-f812-4e00-8787-260b705cd8bd",
  "productndc": "68788-8674",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203458",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 22, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jan 22, 2014"
      }
    ],
    "appl_type": "A"
  },
  "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/1",
  "application_number": "ANDA203458",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "20240523",
  "active_numerator_strength": "500"
}

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