Home NDC 62756-538 Riluzole
Product NDC 62756-538
11-digit product format 627560538
Labeler code 62756
Product ID 62756-538_9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Riluzole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA091417
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 A091417-001 RILUZOLE RILUZOLE 50MG TABLET / ORAL 2013-06-18
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 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091417-001 RILUZOLE 50MG TABLET / ORAL 2013-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091417-001 RILUZOLE 50MG TABLET / ORAL AB 2013-06-18 e64feba35796…
Observed Orange Book normalized TE history# 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 62756-538-18 Riluzole 1000 in 1 BOTTLE TABLET, FILM COATED 1000 10 62756-538-83 Riluzole 30 in 1 BOTTLE TABLET, FILM COATED 30 10 62756-538-86 Riluzole 60 in 1 BOTTLE TABLET, FILM COATED 60 10 62756-538-88 Riluzole 100 in 1 BOTTLE TABLET, FILM COATED 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RILUZOLE ACTIVE INGREDIENT 7LJ087RS6F RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 RILUZOLE ACTIVE MOIETY 7LJ087RS6F RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-538 RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 Current NDC, Legacy NDC, 4 package rows 20200820_4c851be4-f0d0-4b24-baf9-427ddfc6f7b0.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 62756-538-18 62756053818 1000 TABLET, FILM COATED in 1 BOTTLE (62756-538-18) 2013-06-18 0000-00-00 No No Current 62756-538-83 62756053883 30 TABLET, FILM COATED in 1 BOTTLE (62756-538-83) 2013-06-18 0000-00-00 No No Current 62756-538-86 62756053886 60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86) 2013-06-18 0000-00-00 No No Current 62756-538-88 62756053888 100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88) 2013-06-18 0000-00-00 No No Current