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United States · US · US:71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c

Metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133503580
    40 TABLET, FILM COATED in 1 BOTTLE (71335-0358-0)
  • ndc11
    7133503581
    20 TABLET, FILM COATED in 1 BOTTLE (71335-0358-1)
  • ndc11
    7133503582
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0358-2)
  • ndc11
    7133503583
    14 TABLET, FILM COATED in 1 BOTTLE (71335-0358-3)
  • ndc11
    7133503584
    56 TABLET, FILM COATED in 1 BOTTLE (71335-0358-4)
  • ndc11
    7133503585
    21 TABLET, FILM COATED in 1 BOTTLE (71335-0358-5)
  • ndc11
    7133503586
    4 TABLET, FILM COATED in 1 BOTTLE (71335-0358-6)
  • ndc11
    7133503587
    28 TABLET, FILM COATED in 1 BOTTLE (71335-0358-7)
  • ndc11
    7133503588
    100 TABLET, FILM COATED in 1 BOTTLE (71335-0358-8)
  • ndc11
    7133503589
    42 TABLET, FILM COATED in 1 BOTTLE (71335-0358-9)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A203458
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": "71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c",
  "productndc": "71335-0358",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203458",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 22, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jan 22, 2014"
      }
    ],
    "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": "ANDA203458",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "20140601",
  "active_numerator_strength": "500"
}

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