nitazoxanide

Generic: nitazoxanide

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

Drug Facts

Product Profile

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

nitazoxanide 500 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-934
Product ID 70954-934_cd3652fa-a183-4fb6-9a21-73fbeba6fc4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214844
Listing Expiration 2026-12-31
Marketing Start 2025-03-05

Pharmacologic Class

Established (EPC)
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954934
Hyphenated Format 70954-934

Supplemental Identifiers

RxCUI
427163
UPC
0370954934103
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 ANDA214844 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BOTTLE (70954-934-10)
source: ndc

Packages (1)

70954-934-10 6 TABLET in 1 BOTTLE (70954-934-10)

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": "cd3652fa-a183-4fb6-9a21-73fbeba6fc4b", "openfda": {"nui": ["N0000175485"], "upc": ["0370954934103"], "unii": ["SOA12P041N"], "rxcui": ["427163"], "spl_set_id": ["cd3652fa-a183-4fb6-9a21-73fbeba6fc4b"], "pharm_class_epc": ["Antiprotozoal [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE (70954-934-10)", "package_ndc": "70954-934-10", "marketing_start_date": "20250305"}], "brand_name": "Nitazoxanide", "product_id": "70954-934_cd3652fa-a183-4fb6-9a21-73fbeba6fc4b", "dosage_form": "TABLET", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "70954-934", "generic_name": "Nitazoxanide", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitazoxanide", "active_ingredients": [{"name": "NITAZOXANIDE", "strength": "500 mg/1"}], "application_number": "ANDA214844", "marketing_category": "ANDA", "marketing_start_date": "20250305", "listing_expiration_date": "20261231"}