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United States · US · US:43386-551_98a66e10-fb32-46ce-a68b-c21d615f6621
Tinidazole
Orange BookUNIISPLATC G01AF21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeG01AF21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11433865510220 TABLET in 1 BOTTLE (43386-551-02)
- ndc11433865510660 TABLET in 1 BOTTLE (43386-551-06)
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": "43386-551_98a66e10-fb32-46ce-a68b-c21d615f6621",
"productndc": "43386-551",
"dosage_form": "TABLET",
"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
Other records sharing ATC code G01AF21.
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