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United States · US · US:68788-7815_1820c0da-b46b-409a-8e06-98acd1189737

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
    6878878151
    14 TABLET in 1 BOTTLE (68788-7815-1)
  • ndc11
    6878878152
    21 TABLET in 1 BOTTLE (68788-7815-2)
  • ndc11
    6878878153
    30 TABLET in 1 BOTTLE (68788-7815-3)
  • ndc11
    6878878154
    28 TABLET in 1 BOTTLE (68788-7815-4)
  • ndc11
    6878878155
    56 TABLET in 1 BOTTLE (68788-7815-5)
  • ndc11
    6878878157
    42 TABLET in 1 BOTTLE (68788-7815-7)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A206560
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": "68788-7815_1820c0da-b46b-409a-8e06-98acd1189737",
  "productndc": "68788-7815",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206560",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Nov 16, 2016"
      }
    ],
    "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": "ANDA206560",
  "marketing_category": "ANDA",
  "nonproprietary_name": "metronidazole",
  "start_marketing_date": "20201113",
  "active_numerator_strength": "500"
}

Related drugs

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