nitazoxanide

Generic: nitazoxanide

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitazoxanide
Generic Name nitazoxanide
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

nitazoxanide 500 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-100
Product ID 31722-100_4729e7ee-3333-ee2b-e063-6394a90aa85c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218701
Listing Expiration 2026-12-31
Marketing Start 2025-04-15

Pharmacologic Class

Established (EPC)
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722100
Hyphenated Format 31722-100

Supplemental Identifiers

RxCUI
427163
UPC
0331722100311
UNII
SOA12P041N
NUI
N0000175485

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nitazoxanide (source: ndc)
Generic Name nitazoxanide (source: ndc)
Application Number ANDA218701 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (31722-100-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (31722-100-31) / 12 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (31722-100-32) / 6 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

31722-100-30 1 BOTTLE in 1 CARTON (31722-100-30) / 30 TABLET, FILM COATED in 1 BOTTLE 31722-100-31 1 BOTTLE in 1 CARTON (31722-100-31) / 12 TABLET, FILM COATED in 1 BOTTLE 31722-100-32 1 BOTTLE in 1 CARTON (31722-100-32) / 6 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

nitazoxanide (500 mg/1)

Linked Drug Pages (1)

Nitazoxanide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4729e7ee-3333-ee2b-e063-6394a90aa85c", "openfda": {"nui": ["N0000175485"], "upc": ["0331722100311"], "unii": ["SOA12P041N"], "rxcui": ["427163"], "spl_set_id": ["295011e1-f919-4e5a-b9e7-4c784f623a86"], "pharm_class_epc": ["Antiprotozoal [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (31722-100-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "31722-100-30", "marketing_start_date": "20250415"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (31722-100-31)  / 12 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "31722-100-31", "marketing_start_date": "20250415"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (31722-100-32)  / 6 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "31722-100-32", "marketing_start_date": "20250415"}], "brand_name": "Nitazoxanide", "product_id": "31722-100_4729e7ee-3333-ee2b-e063-6394a90aa85c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "31722-100", "generic_name": "Nitazoxanide", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitazoxanide", "active_ingredients": [{"name": "NITAZOXANIDE", "strength": "500 mg/1"}], "application_number": "ANDA218701", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20261231"}