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United States · US · US:13517-135_db1d15c7-d9af-410f-98d5-bd6e8f84c815
Nitazoxanide
Orange BookUNIISPLATC P01AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
Manufacturere5 Pharma, LLC
CountryUS (United States)
ATC codeP01AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1113517135066 TABLET in 1 BOTTLE (13517-135-06)
Annotations
UNII (FDA Substance ID)
SOA12P041N
NITAZOXANIDE
RxCUI 31819
Orange Book
A214844
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "SOA12P041N",
"rxcui": "31819",
"inchikey": "YQNQNVDNTFHQSW-UHFFFAOYSA-N",
"display_name": "NITAZOXANIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"40a7cc30-76cd-49fe-965a-7823c4140d0f": {
"match": "brand_token",
"title": "NITAZOXANIDE TABLET [E5 PHARMA, LLC]",
"spl_version": "2",
"published_date": "2026-01-28"
}
},
"productid": "13517-135_db1d15c7-d9af-410f-98d5-bd6e8f84c815",
"productndc": "13517-135",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214844",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Feb 3, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITAZOXANIDE",
"proprietary_name": "Nitazoxanide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214844",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitazoxanide",
"start_marketing_date": "20260126",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code P01AX11.
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