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United States · US · US:71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680

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
    7133518380
    7 TABLET in 1 BOTTLE (71335-1838-0)
  • ndc11
    7133518381
    21 TABLET in 1 BOTTLE (71335-1838-1)
  • ndc11
    7133518382
    30 TABLET in 1 BOTTLE (71335-1838-2)
  • ndc11
    7133518383
    20 TABLET in 1 BOTTLE (71335-1838-3)
  • ndc11
    7133518384
    60 TABLET in 1 BOTTLE (71335-1838-4)
  • ndc11
    7133518385
    28 TABLET in 1 BOTTLE (71335-1838-5)
  • ndc11
    7133518386
    14 TABLET in 1 BOTTLE (71335-1838-6)
  • ndc11
    7133518387
    40 TABLET in 1 BOTTLE (71335-1838-7)
  • ndc11
    7133518388
    42 TABLET in 1 BOTTLE (71335-1838-8)
  • ndc11
    7133518389
    56 TABLET in 1 BOTTLE (71335-1838-9)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A203974
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": "71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680",
  "productndc": "71335-1838",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203974",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "May 29, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "May 29, 2015"
      }
    ],
    "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": "ANDA203974",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "20150529",
  "active_numerator_strength": "250"
}

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