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United States · US · US:59651-813_d9d4caed-2fa9-4b46-9b7c-d60ec3b879b2

METRONIDAZOLE

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

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

Packs · 1

  • ndc11
    5965181360
    1 TUBE in 1 CARTON (59651-813-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A218941
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": "TOPICAL",
  "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": "59651-813_d9d4caed-2fa9-4b46-9b7c-d60ec3b879b2",
  "productndc": "59651-813",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "218941",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Oct 15, 2024"
      }
    ],
    "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/g",
  "application_number": "ANDA218941",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METRONIDAZOLE",
  "start_marketing_date": "20241015",
  "active_numerator_strength": "10"
}

Related drugs

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