Home NDC 67877-286 Riluzole
Product NDC 67877-286
11-digit product format 678770286
Labeler code 67877
Product ID 67877-286_ab3e90af-a9b7-4a4c-bbd9-31739b8aec19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Riluzole
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA204048
Marketing category ANDA
Marketing start 2016-03-31
Substance RILUZOLE
Active strength 50 mg/1
Pharmacologic classes Benzothiazole [EPC], Benzothiazoles [CS]
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 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 A204048-001 RILUZOLE RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204048-001 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.
Product history page 1 of 2 · 42 observed 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 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204048-001 RILUZOLE 50MG TABLET / ORAL AB RS 2016-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204048-001 RILUZOLE 50MG TABLET / ORAL AB 2016-03-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-286 RILUZOLE TABLET [ASCEND LABORATORIES, LLC] 10 Current NDC, Legacy NDC, 6 package rows 20220511_dd432c13-389e-46b3-8891-0cf1a58800ff.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 Units Marketing start Marketing end Sample Exclude flag Status 67877-286-05 67877028605 500 TABLET in 1 BOTTLE (67877-286-05) 500 tablet 2016-03-31 0000-00-00 No No Current 67877-286-10 67877028610 1000 TABLET in 1 BOTTLE (67877-286-10) 1000 tablet 2016-03-31 0000-00-00 No No Current 67877-286-14 67877028614 10 BLISTER PACK in 1 CARTON (67877-286-14) / 14 TABLET in 1 BLISTER PACK 10 blister pack 2016-03-31 0000-00-00 No No Current 67877-286-60 67877028660 60 TABLET in 1 BOTTLE (67877-286-60) 60 tablet 2016-03-31 0000-00-00 No No Current 67877-286-90 67877028690 90 TABLET in 1 BOTTLE (67877-286-90) 90 tablet 2016-03-31 0000-00-00 No No Current