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United States · US · US:85766-024_4a167a84-a0ca-5805-e063-6294a90a1345

metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    8576602401
    100 TABLET in 1 BOTTLE (85766-024-01)
  • ndc11
    8576602405
    500 TABLET in 1 BOTTLE (85766-024-05)
  • ndc11
    8576602414
    14 TABLET in 1 BOTTLE (85766-024-14)
  • ndc11
    8576602420
    20 TABLET in 1 BOTTLE (85766-024-20)
  • ndc11
    8576602430
    30 TABLET in 1 BOTTLE (85766-024-30)
  • ndc11
    8576602450
    50 TABLET in 1 BOTTLE (85766-024-50)
  • ndc11
    8576602460
    60 TABLET in 1 BOTTLE (85766-024-60)
  • ndc11
    8576602490
    90 TABLET in 1 BOTTLE (85766-024-90)

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": "85766-024_4a167a84-a0ca-5805-e063-6294a90a1345",
  "productndc": "85766-024",
  "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": "500"
}

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