Tinidazole

Orange BookUNIISPLATC G01AF21

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

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeG01AF21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6213583520
20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)

Annotations

UNII (FDA Substance ID)

033KF7V46H

TINIDAZOLE

RxCUI 10612

Orange Book

A202044

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": "62135-835_1d71c803-2d38-ccc8-e063-6294a90a7923",
  "productndc": "62135-835",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202044",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Apr 30, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Apr 30, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TINIDAZOLE",
  "proprietary_name": "Tinidazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202044",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tinidazole",
  "start_marketing_date": "20120430",
  "active_numerator_strength": "500"
}

Related drugs

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