FDA.reportPublic FDA data

TIGLUTIK

Product NDC
70726-0303
11-digit product format
707260303
Labeler code
70726
Product ID
70726-0303_4746e22f-8ca7-9149-e063-6294a90aea8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Riluzole
Dosage form
LIQUID
Route
ORAL
Labeler
EDW PHARMA, INC
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

Additional Listing Data#

Finished product
Yes
Brand name base
TIGLUTIK
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RILUZOLE50 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LJ087RS6F
Rxcui2058147, 2059266

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
71bcb10f-c731-4369-817a-3db2209427adProduct name220250317
3e7d95d4-de41-5244-3ffc-380f6a049665Product name420200527
1d8c2f24-074a-49fc-a7ba-0d39b478c02fProduct name120200507

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70726-0303-22023-08-31C16284748780-19d75b9d0-38c5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIGLUTIK® safely and effectively. See full prescribing information for TIGLUTIK. TIGLUTIK (riluzole) oral suspension Initial U.S. Approval: 1995
70726-0303-22023-01-30C16284748780-19d75b9d0-38c5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIGLUTIK® safely and effectively. See full prescribing information for TIGLUTIK. TIGLUTIK (riluzole) oral suspension Initial U.S. Approval: 1995
70726-0303-22020-03-12C16284748780-19d75b9d0-38c5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIGLUTIK® safely and effectively. See full prescribing information for TIGLUTIK. TIGLUTIK (riluzole) oral suspension Initial U.S. Approval: 1995
70726-0303-22020-01-31C16284748780-19d75b9d0-38c5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIGLUTIK® safely and effectively. See full prescribing information for TIGLUTIK. TIGLUTIK (riluzole) oral suspension Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70726-0303-1TIGLUTIK2 in 1 CARTONLIQUID221
70726-0303-2TIGLUTIK300 mL in 1 BOTTLE, PLASTICLIQUID30021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70726-0303-1ML - Milliliter70726-03038d41ee9e-6174-4dc1-8a7a-289efc7b762412018-10-11
70726-0303-2ML - Milliliter70726-03031482b307-24ba-439e-9a33-52682f5ecd6f12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70726-0303TIGLUTIK (RILUZOLE) LIQUID [EDW PHARMA, INC]19Current NDC, Legacy NDC, 2 package rows20240210_75d68f19-4208-109e-e053-2991aa0ac857.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058147riluzole 50 MG in 10 mL Oral SuspensionPSN75d68f19-4208-109e-e053-2991aa0ac85721
2059266Tiglutik 50 MG in 10 mL Oral SuspensionPSN75d68f19-4208-109e-e053-2991aa0ac85721
2059266riluzole 5 MG/ML Oral Suspension [Tiglutik]SBD75d68f19-4208-109e-e053-2991aa0ac85721
2058147riluzole 5 MG/ML Oral SuspensionSCD75d68f19-4208-109e-e053-2991aa0ac85721
2058147riluzole 25 MG per 5 mL Oral SuspensionSY75d68f19-4208-109e-e053-2991aa0ac85721
2058147riluzole 50 MG per 10 mL Oral SuspensionSY75d68f19-4208-109e-e053-2991aa0ac85721
2059266Tiglutik 25 MG per 5 ML Oral SuspensionSY75d68f19-4208-109e-e053-2991aa0ac85721
2059266Tiglutik 5 MG/ML Oral SuspensionSY75d68f19-4208-109e-e053-2991aa0ac85721
2059266Tiglutik 50 MG per 10 ML Oral SuspensionSY75d68f19-4208-109e-e053-2991aa0ac85721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70726-0303-1707260303012 BOTTLE, PLASTIC in 1 CARTON (70726-0303-1) / 300 mL in 1 BOTTLE, PLASTIC (70726-0303-2) 2018-09-21NoNoHistorical
70726-0303-2707260303022 BOTTLE, PLASTIC in 1 CARTON (70726-0303-2) > 300 mL in 1 BOTTLE, PLASTIC (70726-0303-1) 2018-09-210000-00-00NoNoCurrent