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United States · US · US:46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a

Metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

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

Packs · 4

  • ndc11
    4670802130
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30)
  • ndc11
    4670802131
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31)
  • ndc11
    4670802150
    50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-50)
  • ndc11
    4670802171
    500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-71)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A090222
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": "46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a",
  "productndc": "46708-021",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090222",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "750MG",
        "product_no": "001",
        "approval_date": "May 5, 2010"
      }
    ],
    "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": "ANDA090222",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "20100507",
  "active_numerator_strength": "750"
}

Related drugs

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