FDA.reportPublic FDA data

Teglutik

Product NDC
70726-0305
11-digit product format
707260305
Labeler code
70726
Product ID
70726-0305_4746c4d8-402a-0390-e063-6294a90a7fc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Riluzole
Dosage form
LIQUID
Route
ORAL
Labeler
EDW PHARMA
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2024-03-08
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7LJ087RS6FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2058147Internal RxNorm lookup
2675565Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
125fdd37-02f7-a610-e063-6294a90a009dAvailable on FDA.report

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
70726-0305-1Teglutik300 mL in 1 BOTTLE, PLASTICLIQUID3002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70726-0305-1ML - Milliliter70726-03056fe834f4-9e96-4ddf-a1b0-4b9a3a8316c812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70726-0305TEGLUTIK (RILUZOLE) LIQUID [EDW PHARMA]1Current NDC, 1 package rows20240308_125fdd37-02f7-a610-e063-6294a90a009d.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TeglutikRILUZOLEEDW PHARMA125fdd37-02f7-a610-e063-6294a90a009d2025-12-31Exact identifier
ndc (product): 70726-0305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058147riluzole 50 MG in 10 mL Oral SuspensionPSN125fdd37-02f7-a610-e063-6294a90a009d2
2675565TEGLUTIK 5 MG/mL Oral SuspensionPSN125fdd37-02f7-a610-e063-6294a90a009d2
2675565riluzole 5 MG/ML Oral Suspension [Teglutik]SBD125fdd37-02f7-a610-e063-6294a90a009d2
2058147riluzole 5 MG/ML Oral SuspensionSCD125fdd37-02f7-a610-e063-6294a90a009d2
2058147riluzole 25 MG per 5 mL Oral SuspensionSY125fdd37-02f7-a610-e063-6294a90a009d2
2058147riluzole 50 MG per 10 mL Oral SuspensionSY125fdd37-02f7-a610-e063-6294a90a009d2
2675565Teglutik 5 MG/mL Oral SuspensionSY125fdd37-02f7-a610-e063-6294a90a009d2
2675565Teglutik 50 MG per 10 mL Oral SuspensionSY125fdd37-02f7-a610-e063-6294a90a009d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70726-0305-170726030501300 mL in 1 BOTTLE, PLASTIC (70726-0305-1) 300 ml2024-03-08NoNoCurrent