nitazoxanide

Generic: nitazoxanide

Labeler: e5 pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitazoxanide
Generic Name nitazoxanide
Labeler e5 pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nitazoxanide 500 mg/1

Manufacturer
e5 Pharma, LLC

Identifiers & Regulatory

Product NDC 13517-135
Product ID 13517-135_db1d15c7-d9af-410f-98d5-bd6e8f84c815
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214844
Listing Expiration 2027-12-31
Marketing Start 2026-01-26

Pharmacologic Class

Established (EPC)
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13517135
Hyphenated Format 13517-135

Supplemental Identifiers

RxCUI
427163
UPC
0313517135067
UNII
SOA12P041N
NUI
N0000175485

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 (13517-135-06)
source: ndc

Packages (1)

13517-135-06 6 TABLET in 1 BOTTLE (13517-135-06)

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": "db1d15c7-d9af-410f-98d5-bd6e8f84c815", "openfda": {"nui": ["N0000175485"], "upc": ["0313517135067"], "unii": ["SOA12P041N"], "rxcui": ["427163"], "spl_set_id": ["40a7cc30-76cd-49fe-965a-7823c4140d0f"], "pharm_class_epc": ["Antiprotozoal [EPC]"], "manufacturer_name": ["e5 Pharma, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE (13517-135-06)", "package_ndc": "13517-135-06", "marketing_start_date": "20260126"}], "brand_name": "Nitazoxanide", "product_id": "13517-135_db1d15c7-d9af-410f-98d5-bd6e8f84c815", "dosage_form": "TABLET", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "13517-135", "generic_name": "Nitazoxanide", "labeler_name": "e5 Pharma, LLC", "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": "20260126", "listing_expiration_date": "20271231"}