Home NDC 64980-526 Nitazoxanide
Product NDC 64980-526
11-digit product format 649800526
Labeler code 64980
Product ID 64980-526_9ee8087a-d001-42a9-ae98-6e4cbf93caa1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitazoxanide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA213820
Marketing category ANDA
Marketing start 2020-11-27
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 A213820-001 NITAZOXANIDE NITAZOXANIDE 500MG TABLET / ORAL AB RS 2020-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213820-001 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 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB RS 2020-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB RS 2020-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB RS 2020-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB RS 2020-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB RS 2020-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL RS 2020-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL RS 2020-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL RS 2020-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL RS 2020-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB 2020-11-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213820-001 NITAZOXANIDE 500MG TABLET / ORAL AB RS 2020-11-27 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A213820-001 CGT 2021-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213820-001 CGT 2021-06-05 87673890dc5c…
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 64980-526-03 Nitazoxanide 30 in 1 BOTTLE TABLET, FILM COATED 30 9 64980-526-21 Nitazoxanide 12 in 1 BOTTLE TABLET, FILM COATED 12 9 64980-526-60 Nitazoxanide 6 in 1 BOTTLE TABLET, FILM COATED 6 9 64980-526-81 Nitazoxanide 18 in 1 BOTTLE TABLET, FILM COATED 18 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-526 NITAZOXANIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 8 Current NDC, Legacy NDC, 4 package rows 20250424_c0dc0656-3c46-43f9-adea-5285c522cef8.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64980-526-03 64980052603 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) 2020-11-27 0000-00-00 No No Current 64980-526-21 64980052621 12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) 2020-11-27 0000-00-00 No No Current 64980-526-60 64980052660 6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60) 2020-11-27 0000-00-00 No No Current 64980-526-81 64980052681 18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81) 2020-11-27 0000-00-00 No No Current