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United States · US · US:31722-100_4729e7ee-3333-ee2b-e063-6394a90aa85c
Nitazoxanide
Orange BookUNIISPLATC P01AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeP01AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1131722100301 BOTTLE in 1 CARTON (31722-100-30) / 30 TABLET, FILM COATED in 1 BOTTLE
- ndc1131722100311 BOTTLE in 1 CARTON (31722-100-31) / 12 TABLET, FILM COATED in 1 BOTTLE
- ndc1131722100321 BOTTLE in 1 CARTON (31722-100-32) / 6 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
SOA12P041N
NITAZOXANIDE
RxCUI 31819
Orange Book
A218701
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": "31722-100_4729e7ee-3333-ee2b-e063-6394a90aa85c",
"productndc": "31722-100",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218701",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Apr 15, 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": "ANDA218701",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitazoxanide",
"start_marketing_date": "20250415",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code P01AX11.
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