metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeD06BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7642080001
100 TABLET in 1 BOTTLE (76420-800-01)
ndc11
7642080005
500 TABLET in 1 BOTTLE (76420-800-05)
ndc11
7642080021
21 TABLET in 1 BOTTLE (76420-800-21)
ndc11
7642080025
250 TABLET in 1 BOTTLE (76420-800-25)
ndc11
7642080030
30 TABLET in 1 BOTTLE (76420-800-30)
ndc11
7642080060
60 TABLET in 1 BOTTLE (76420-800-60)
ndc11
7642080090
90 TABLET in 1 BOTTLE (76420-800-90)

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": "76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390",
  "productndc": "76420-800",
  "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": "20190223",
  "active_numerator_strength": "250"
}

Related drugs

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