TIGLUTIK (riluzole) oral suspension

Manufacturer: Italfarmaco SPA | Italfarmaco S.A.
Effective date: 2026-07-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: daily-update
Hydrated at: 2026-08-04 03:35:43

Label at a glance#

ProductTIGLUTIK

Active ingredientRILUZOLE

Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 300 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11797-210-01

R_x only

Tiglutik^®
riluzole
oral suspension
50 mg/10 mL (5 mg/mL)

For Oral Administration
Shake gently before use

Contents of this package:

Two bottles, each containing 300 mL
Two 10 mL oral syringes
Two syringe bottle adapters
Two syringe tip caps
One Prescribing Information, including
Instructions for Use

This product is a liquid suspension and is
supplied with syringes for oral administration.
Before use, please read the enclosed
Prescribing Information.

600 mL (two bottles/300 mL each)
Not To Be Dispensed Separately

PRINCIPAL DISPLAY PANEL - 300 mL Bottle Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

TIGLUTIK
Riluzole
MAGNESIUM ALUMINUM SILICATE
SORBITOL
POLYOXYL 20 CETOSTEARYL ETHER
WATER
SACCHARIN SODIUM
SILICON DIOXIDE
DIMETHICONE, UNSPECIFIED
SODIUM LAURYL SULFATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11797-210	11797-210-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
SORBITOL	506T60A25R	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
DIMETHICONE, UNSPECIFIED	92RU3N3Y1O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
XANTHAN GUM	TTV12P4NEE	IACT
RILUZOLE	7LJ087RS6F	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 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
2026-10-15 13:18:30	2026-09	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N209080-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209080-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209080-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209080-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209080-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209080-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209080-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209080-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209080-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209080-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209080-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209080-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209080-001	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209080-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`c2088c7a36db…`
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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIGLUTIK	RILUZOLE	Italfarmaco SPA	20b7165a-eb4d-42a0-b2d8-16eff90a214e	2026-07-29		Exact identifier ndc (package): 11797-210-01 ndc (product): 11797-210 ndc11 (package): 11797021001 spl id: 2ba33fab-05a6-42db-9b4a-277bb3a30f29 spl set id: 20b7165a-eb4d-42a0-b2d8-16eff90a214e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.