Home NDC 70954-934 Nitazoxanide
Product NDC 70954-934
11-digit product format 709540934
Labeler code 70954
Product ID 70954-934_cd3652fa-a183-4fb6-9a21-73fbeba6fc4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitazoxanide
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA214844
Marketing category ANDA
Marketing start 2025-03-05
Substance NITAZOXANIDE
Active strength 500 mg/1
Pharmacologic classes Antiprotozoal [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 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 70954-934-10 Nitazoxanide 6 in 1 BOTTLE TABLET 6 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-934 NITAZOXANIDE TABLET [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250308_cd3652fa-a183-4fb6-9a21-73fbeba6fc4b.zip
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 70954-934-10 70954093410 6 TABLET in 1 BOTTLE (70954-934-10) 6 tablet 2025-03-05 No No Current