Home NDC 42291-775 Riluzole
Product NDC 42291-775
11-digit product format 422910775
Labeler code 42291
Product ID 42291-775_4c362542-247a-50f1-e063-6394a90a5065
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name riluzole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA206045
Marketing category ANDA
Marketing start 2020-10-07
Substance RILUZOLE
Active strength 50 mg/1
Pharmacologic classes Benzothiazole [EPC], Benzothiazoles [CS]
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 42 .
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 A206045-001 RILUZOLE RILUZOLE 50MG TABLET / ORAL AB 2019-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206045-001 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 2026-08-18 06:07:40 2026-07 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206045-001 RILUZOLE 50MG TABLET / ORAL AB 2019-12-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Riluzole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RILUZOLE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7LJ087RS6F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199206 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 42291-775-60 Riluzole 60 in 1 BOTTLE TABLET, FILM COATED 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-775 RILUZOLE TABLET, FILM COATED [AVKARE] 3 Current NDC, Legacy NDC, 1 package rows 20240111_b117b981-476c-f9b8-e053-2995a90aee5f.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 Marketing start Marketing end Sample Exclude flag Status 42291-775-60 42291077560 60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60) 2020-10-07 0000-00-00 No No Current