Home NDC 13517-135 Nitazoxanide
Product NDC 13517-135
11-digit product format 135170135
Labeler code 13517
Product ID 13517-135_db1d15c7-d9af-410f-98d5-bd6e8f84c815
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitazoxanide
Dosage form TABLET
Route ORAL
Labeler e5 Pharma, LLC
Application ANDA214844
Marketing category ANDA
Marketing start 2026-01-26
Substance NITAZOXANIDE
Active strength 500 mg/1
Pharmacologic classes Antiprotozoal [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214844-001 NITAZOXANIDE NITAZOXANIDE 500MG TABLET / ORAL AB 2025-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214844-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214844-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2025-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214844-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2025-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214844-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2025-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214844-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2025-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214844-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2025-02-03 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214844-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2025-02-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nitazoxanide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITAZOXANIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOA12P041N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 427163 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13517-135-06 Nitazoxanide 6 in 1 BOTTLE TABLET 6 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 13517-135-06 13517013506 6 TABLET in 1 BOTTLE (13517-135-06) 6 tablet 2026-01-26 No No Current