Teglutik

Product NDC
70726-0304
11-digit product format
707260304
Labeler code
70726
Product ID
70726-0304_4746bd79-5116-423c-e063-6394a90a17e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Riluzole
Dosage form
LIQUID
Route
ORAL
Labeler
EDW PHARMA, INC
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2024-01-19
Substance
RILUZOLE
Active strength
5 mg/mL
Pharmacologic classes
Benzothiazole [EPC], Benzothiazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Teglutik
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RILUZOLE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LJ087RS6F
Rxcui2058147, 2675565

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70726-0304-1Teglutik300 mL in 1 BOTTLE, PLASTICLIQUID3007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70726-0304-1ML - Milliliter70726-03042fd78d7a-b3fa-489b-8260-51099273847812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70726-0304TEGLUTIK (RILUZOLE) LIQUID [EDW PHARMA, INC]6Current NDC, 1 package rows20240210_0f2b5cfc-a23d-699a-e063-6394a90a67d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058147riluzole 50 MG in 10 mL Oral SuspensionPSN0f2b5cfc-a23d-699a-e063-6394a90a67d17
2675565TEGLUTIK 5 MG/mL Oral SuspensionPSN0f2b5cfc-a23d-699a-e063-6394a90a67d17
2675565riluzole 5 MG/ML Oral Suspension [Teglutik]SBD0f2b5cfc-a23d-699a-e063-6394a90a67d17
2058147riluzole 5 MG/ML Oral SuspensionSCD0f2b5cfc-a23d-699a-e063-6394a90a67d17
2058147riluzole 25 MG per 5 mL Oral SuspensionSY0f2b5cfc-a23d-699a-e063-6394a90a67d17
2058147riluzole 50 MG per 10 mL Oral SuspensionSY0f2b5cfc-a23d-699a-e063-6394a90a67d17
2675565Teglutik 5 MG/mL Oral SuspensionSY0f2b5cfc-a23d-699a-e063-6394a90a67d17
2675565Teglutik 50 MG per 10 mL Oral SuspensionSY0f2b5cfc-a23d-699a-e063-6394a90a67d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70726-0304-170726030401300 mL in 1 BOTTLE, PLASTIC (70726-0304-1) 300 ml2024-01-19NoNoHistorical