nitazoxanide

Generic: nitazoxanide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitazoxanide
Generic Name nitazoxanide
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

nitazoxanide 500 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-526
Product ID 64980-526_9ee8087a-d001-42a9-ae98-6e4cbf93caa1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213820
Listing Expiration 2026-12-31
Marketing Start 2020-11-27

Pharmacologic Class

Established (EPC)
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980526
Hyphenated Format 64980-526

Supplemental Identifiers

RxCUI
427163
UPC
0364980526036
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 ANDA213820 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03)
  • 12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21)
  • 6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60)
  • 18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81)
source: ndc

Packages (4)

64980-526-03 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) 64980-526-21 12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) 64980-526-60 6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60) 64980-526-81 18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81)

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": "9ee8087a-d001-42a9-ae98-6e4cbf93caa1", "openfda": {"nui": ["N0000175485"], "upc": ["0364980526036"], "unii": ["SOA12P041N"], "rxcui": ["427163"], "spl_set_id": ["c0dc0656-3c46-43f9-adea-5285c522cef8"], "pharm_class_epc": ["Antiprotozoal [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03)", "package_ndc": "64980-526-03", "marketing_start_date": "20201127"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21)", "package_ndc": "64980-526-21", "marketing_start_date": "20201127"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60)", "package_ndc": "64980-526-60", "marketing_start_date": "20201127"}, {"sample": false, "description": "18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81)", "package_ndc": "64980-526-81", "marketing_start_date": "20201127"}], "brand_name": "Nitazoxanide", "product_id": "64980-526_9ee8087a-d001-42a9-ae98-6e4cbf93caa1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "64980-526", "generic_name": "Nitazoxanide", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitazoxanide", "active_ingredients": [{"name": "NITAZOXANIDE", "strength": "500 mg/1"}], "application_number": "ANDA213820", "marketing_category": "ANDA", "marketing_start_date": "20201127", "listing_expiration_date": "20261231"}