Tinidazole

Orange BookUNIISPLATC G01AF21

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBioComp Pharma, Inc.

CountryUS (United States)

ATC codeG01AF21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4452345012
12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)
ndc11
4452345020
20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)

Annotations

UNII (FDA Substance ID)

033KF7V46H

TINIDAZOLE

RxCUI 10612

Orange Book

N021618

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "033KF7V46H",
    "rxcui": "10612",
    "inchikey": "HJLSLZFTEKNLFI-UHFFFAOYSA-N",
    "display_name": "TINIDAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6f3ce597-64c1-4204-a67a-8b6f6e7e8bca": {
      "match": "brand_token",
      "title": "TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]",
      "spl_version": "9",
      "published_date": "2025-12-19"
    }
  },
  "productid": "44523-450_44ecbffa-e4aa-9dd3-e063-6394a90a4d48",
  "productndc": "44523-450",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021618",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "May 17, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "May 17, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TINIDAZOLE",
  "proprietary_name": "Tinidazole",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021618",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "tinidazole",
  "start_marketing_date": "20250320",
  "active_numerator_strength": "500"
}

Related drugs

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