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United States · US · US:42799-208_462f7240-9709-4782-e063-6294a90a9e28
Tinidazole
Orange BookUNIISPLATC G01AF21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeG01AF21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11427992080120 TABLET in 1 BOTTLE (42799-208-01)
- ndc11427992080260 TABLET in 1 BOTTLE (42799-208-02)
Annotations
UNII (FDA Substance ID)
033KF7V46H
TINIDAZOLE
RxCUI 10612
Orange Book
A203808
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": "42799-208_462f7240-9709-4782-e063-6294a90a9e28",
"productndc": "42799-208",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203808",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Aug 4, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Aug 4, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TINIDAZOLE",
"proprietary_name": "Tinidazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203808",
"marketing_category": "ANDA",
"nonproprietary_name": "Tinidazole",
"start_marketing_date": "20191220",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G01AF21.
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