FDA.reportPublic FDA data

TOUJEO Max

Product NDC
50090-4177
11-digit product format
500904177
Labeler code
50090
Product ID
50090-4177_49a2c875-471e-4f82-90bd-b6997234d4e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA206538
Marketing category
BLA
Marketing start
2015-02-15
Substance
INSULIN GLARGINE
Active strength
300 U/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE300 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ZM8CX04RZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2002419Internal RxNorm lookup
2002420Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9e2da77-dd6b-4b0e-9065-a13f87955fe1Product name120220720
5f5c996a-6aad-4f9a-86a2-e09dc8b634cbProduct name120220207
1c45812e-8815-4d17-83e9-a18ac8df9badProduct name120210105
256d5b66-c6d0-4302-bcdf-00cf53e72c3bProduct name220200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8Product name220200323
e43198b7-315b-480b-8517-8809d5ca232aProduct name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4177-0TOUJEO Max3 mL in 1 SYRINGEINJECTION, SOLUTION39
50090-4177-0TOUJEO Max2 in 1 CARTONINJECTION, SOLUTION29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4177-0ML - Milliliter50090-417785e6f487-01cf-40ef-b3d2-ebe8bfd7c02312021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4177TOUJEO MAX (INSULIN GLARGINE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20230713_620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab9.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOUJEOINSULIN GLARGINESanofi-Aventis U.S. LLCc9561d96-124d-48ca-982f-0aa1575bff362025-05-30Warnings, Adverse reactionsExact identifier
application number: BLA206538
Insulin glargine U-300 MaxINSULIN GLARGINESanofi-Aventis U.S. LLC99ea856d-9562-443a-9422-1006a3cff2f42025-05-30Warnings, Adverse reactionsExact identifier
application number: BLA206538
TOUJEO MaxINSULIN GLARGINEA-S Medication Solutions620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab92023-07-12Warnings, Adverse reactionsExact identifier
application number: BLA206538
ndc (product): 50090-4177
TOUJEOINSULIN GLARGINEA-S Medication Solutions257ca17b-6ff7-4f2e-9037-4c185bac57682023-04-27Warnings, Adverse reactionsExact identifier
application number: BLA206538

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
206538Toujeoinsulin glargine351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002419insulin glargine 300 UNT/ML in 3 ML Pen InjectorPSN620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab99
2002420Toujeo Max 300 UNT/ML in 3 ML Pen InjectorPSN620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab99
20024203 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]SBD620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab99
20024193 ML insulin glargine 300 UNT/ML Pen InjectorSCD620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab99
20024203 ML Toujeo 300 UNT/ML Pen InjectorSY620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab99
2002419insulin glargine 300 UNT/ML per 3 ML Pen InjectorSY620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab99
2002420Toujeo 300 UNT/ML per 3 ML Pen InjectorSY620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4177-0500904177002 SYRINGE in 1 CARTON (50090-4177-0) / 3 mL in 1 SYRINGE2 syringe2019-03-110000-00-00NoNoCurrent