metronidazole

In shortageOrange BookUNIISPLATC D06BX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMethod Pharmaceuticals LLC

CountryUS (United States)

ATC codeD06BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5865793301
100 BLISTER PACK in 1 CARTON (58657-933-01) / 1 TABLET in 1 BLISTER PACK (58657-933-10)
ndc11
5865793305
50 BLISTER PACK in 1 CARTON (58657-933-05) / 1 TABLET in 1 BLISTER PACK (58657-933-10)

Annotations

UNII (FDA Substance ID)

140QMO216E

METRONIDAZOLE

RxCUI 6922

Orange Book

A070772

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": "58657-933_51018185-a67f-bf2c-e063-6394a90adca5",
  "productndc": "58657-933",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070772",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 16, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jul 16, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "125MG",
        "product_no": "003",
        "approval_date": "Oct 29, 2024"
      }
    ],
    "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": "ANDA070772",
  "marketing_category": "ANDA",
  "nonproprietary_name": "metronidazole",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "250"
}

Related drugs

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