Home NDC 68462-381 riluzole
Product NDC 68462-381
11-digit product format 684620381
Labeler code 68462
Product ID 68462-381_e8a81e60-47b6-4097-9e49-48eb88e694f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name riluzole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA091394
Marketing category ANDA
Marketing start 2013-06-18
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 A091394-001 RILUZOLE RILUZOLE 50MG TABLET / ORAL AB 2013-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091394-001 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 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091394-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 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 2026-12-31 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 68462-381-10 riluzole 1000 in 1 BOTTLE TABLET, FILM COATED 1000 12 68462-381-60 riluzole 60 in 1 BOTTLE TABLET, FILM COATED 60 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RILUZOLE ACTIVE INGREDIENT 7LJ087RS6F RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 RILUZOLE ACTIVE MOIETY 7LJ087RS6F RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-381 RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 12 Current NDC, Legacy NDC, 2 package rows 20240104_f1ce57e8-d3fe-422c-8724-3101c258898a.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 68462-381-10 68462038110 1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10) 2013-06-18 0000-00-00 No No Current 68462-381-60 68462038160 60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60) 2013-06-18 0000-00-00 No No Current