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United States · US · US:64980-426_8dbd79dd-9243-4413-aa01-ba1301573a48
Tindazole
Orange BookUNIISPLATC G01AF21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeG01AF21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11649804260220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02)
Annotations
UNII (FDA Substance ID)
033KF7V46H
TINIDAZOLE
RxCUI 10612
Orange Book
A202489
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": {
"32167dd7-5d37-457b-9b00-cd735de6b060": {
"match": "brand_token",
"title": "TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]",
"spl_version": "6",
"published_date": "2025-09-22"
}
},
"productid": "64980-426_8dbd79dd-9243-4413-aa01-ba1301573a48",
"productndc": "64980-426",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202489",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Oct 9, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Oct 9, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TINIDAZOLE",
"proprietary_name": "Tindazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202489",
"marketing_category": "ANDA",
"nonproprietary_name": "Tinidazole",
"start_marketing_date": "20131009",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code G01AF21.
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