Home NDC 0378-4145-91 Riluzole
Product NDC 0378-4145
Requested package NDC 0378-4145-91
11-digit product format 003784145
Labeler code 0378
Product ID 0378-4145_75a73f3c-36f0-482c-87fc-c5bab212d4e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name riluzole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA203042
Marketing category ANDA
Marketing start 2013-07-22
Marketing end 0000-00-00
Substance RILUZOLE
Active strength 50 mg/1
Pharmacologic classes Benzothiazole [EPC],Benzothiazoles [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-4145 0378-4145-91 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0378-4145 0378-4145-91 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A203042-001 RILUZOLE RILUZOLE 50MG TABLET / ORAL 2013-07-01
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 A203042-001 RILUZOLE 50MG TABLET / ORAL 2013-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203042-001 RILUZOLE 50MG TABLET / ORAL 2013-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203042-001 RILUZOLE 50MG TABLET / ORAL 2013-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203042-001 RILUZOLE 50MG TABLET / ORAL AB 2013-07-01 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RILUZOLE ACTIVE INGREDIENT 7LJ087RS6F RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 RILUZOLE ACTIVE MOIETY 7LJ087RS6F RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-4145 RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 Legacy NDC 20250117_97457622-5727-4b07-9e72-edd784b2d76d.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-4145-91 00378414591 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4145-91) 2013-07-22 0000-00-00 No No Current