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United States · US · US:62135-836_128cb585-c2bf-5e15-e063-6394a90a04aa

Metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

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

Packs · 1

  • ndc11
    6213583650
    50 CAPSULE in 1 BOTTLE (62135-836-50)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A076522
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": "62135-836_128cb585-c2bf-5e15-e063-6394a90a04aa",
  "productndc": "62135-836",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076522",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "001",
        "approval_date": "Jan 29, 2004"
      }
    ],
    "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": "ANDA076522",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "20040129",
  "active_numerator_strength": "375"
}

Related drugs

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