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United States · US · US:63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e

Metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6318751114
    14 TABLET in 1 BOTTLE (63187-511-14)
  • ndc11
    6318751121
    21 TABLET in 1 BOTTLE (63187-511-21)
  • ndc11
    6318751128
    28 TABLET in 1 BOTTLE (63187-511-28)
  • ndc11
    6318751130
    30 TABLET in 1 BOTTLE (63187-511-30)
  • ndc11
    6318751160
    60 TABLET in 1 BOTTLE (63187-511-60)
  • ndc11
    6318751190
    90 TABLET in 1 BOTTLE (63187-511-90)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A070027
AB
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": "63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e",
  "productndc": "63187-511",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070027",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Nov 6, 1984"
      }
    ],
    "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": "ANDA070027",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "19900930",
  "active_numerator_strength": "250"
}

Related drugs

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