TOUJEO

Product NDC
50090-2193
11-digit product format
500902193
Labeler code
50090
Product ID
50090-2193_cab55702-5aa0-48a9-9989-36255bffb0e4
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE300 U/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ
Rxcui1604539, 1604544

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
50090-2193-0TOUJEO3 in 1 CARTONINJECTION, SOLUTION313
50090-2193-0TOUJEO1.5 mL in 1 SYRINGEINJECTION, SOLUTION1.513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2193-0ML - Milliliter50090-21937b16f8a5-708b-401e-9d24-993758eb9ede12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2193TOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20230429_257ca17b-6ff7-4f2e-9037-4c185bac5768.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1604539insulin glargine 300 UNT/ML in 1.5 ML Pen InjectorPSN257ca17b-6ff7-4f2e-9037-4c185bac576813
1604544Toujeo 300 UNT/ML in 1.5 ML Pen InjectorPSN257ca17b-6ff7-4f2e-9037-4c185bac576813
16045441.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]SBD257ca17b-6ff7-4f2e-9037-4c185bac576813
16045391.5 ML insulin glargine 300 UNT/ML Pen InjectorSCD257ca17b-6ff7-4f2e-9037-4c185bac576813
16045441.5 ML Toujeo 300 UNT/ML Pen InjectorSY257ca17b-6ff7-4f2e-9037-4c185bac576813
1604539insulin glargine 300 UNT/ML per 1.5 ML Pen InjectorSY257ca17b-6ff7-4f2e-9037-4c185bac576813
1604544Toujeo 300 UNT/ML 1.5 ML Prefilled PenSY257ca17b-6ff7-4f2e-9037-4c185bac576813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2193-0500902193003 SYRINGE in 1 CARTON (50090-2193-0) / 1.5 mL in 1 SYRINGE3 syringe2015-10-260000-00-00NoNoCurrent