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United States · US · US:64980-526_9ee8087a-d001-42a9-ae98-6e4cbf93caa1
Nitazoxanide
Orange BookUNIISPLATC P01AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeP01AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11649805260330 TABLET, FILM COATED in 1 BOTTLE (64980-526-03)
- ndc11649805262112 TABLET, FILM COATED in 1 BOTTLE (64980-526-21)
- ndc1164980526606 TABLET, FILM COATED in 1 BOTTLE (64980-526-60)
- ndc11649805268118 TABLET, FILM COATED in 1 BOTTLE (64980-526-81)
Annotations
UNII (FDA Substance ID)
SOA12P041N
NITAZOXANIDE
RxCUI 31819
Orange Book
A213820
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": "64980-526_9ee8087a-d001-42a9-ae98-6e4cbf93caa1",
"productndc": "64980-526",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213820",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Nov 27, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITAZOXANIDE",
"proprietary_name": "Nitazoxanide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213820",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitazoxanide",
"start_marketing_date": "20201127",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code P01AX11.
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