Home NDC 11797-210 TIGLUTIK
Product NDC 11797-210
11-digit product format 117970210
Labeler code 11797
Product ID 11797-210_2ba33fab-05a6-42db-9b4a-277bb3a30f29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Riluzole
Dosage form SUSPENSION
Route ORAL
Labeler Italfarmaco SPA
Application NDA209080
Marketing category NDA
Marketing start 2018-09-21
Substance RILUZOLE
Active strength 50 mg/10mL
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 43 .
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 N209080-001 TIGLUTIK KIT RILUZOLE 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209080-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27
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 · 43 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 2026-09-14 22:38:34 2026-08 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL AB RLD, RS 2018-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209080-001 TIGLUTIK KIT 50MG/10ML SUSPENSION / ORAL RLD, RS 2018-09-05 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209080-001 8765150 2029-03-12 U-2401 Drug product 2018-09-27 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TIGLUTIK
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RILUZOLE 50 mg/10mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2058147 Internal RxNorm lookup 2059266 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 11797-210-01 11797021001 2 BOTTLE, PLASTIC in 1 CARTON (11797-210-01) / 300 mL in 1 BOTTLE, PLASTIC 2018-09-21 No No Current