FDA.reportPublic FDA data

TOUJEO

Product NDC
0024-5869
11-digit product format
000245869
Labeler code
0024
Product ID
0024-5869_49201ad7-68f7-407c-959f-852591703f96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
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, 2002419, 2002420

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
0024-5869-00TOUJEO1 in 1 CARTONINJECTION, SOLUTION125
0024-5869-00TOUJEO1.5 mL in 1 SYRINGEINJECTION, SOLUTION1.525
0024-5869-01TOUJEO1.5 mL in 1 SYRINGEINJECTION, SOLUTION1.525
0024-5869-03TOUJEO3 in 1 CARTONINJECTION, SOLUTION325

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5869-00ML - Milliliter0024-586937c667e4-ce5b-4f9f-8bf7-b7ff3b00070c12021-06-02
0024-5869-01ML - Milliliter0024-586943f5217b-8e34-49dd-b0be-c1b2d5a05a9712017-11-06
0024-5869-03ML - Milliliter0024-5869ce96366d-7fde-4e4b-92ff-e6cdc6ac9ef712015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
insulin glargineACTIVE INGREDIENT2ZM8CX04RZTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
insulin glargineACTIVE MOIETY2ZM8CX04RZTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
glycerinINACTIVE INGREDIENTPDC6A3C0OXTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
metacresolINACTIVE INGREDIENTGGO4Y809LOTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
waterINACTIVE INGREDIENT059QF0KO0RTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7
zincINACTIVE INGREDIENTJ41CSQ7QDSTOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5869TOUJEO (INSULIN GLARGINE) INJECTION, SOLUTION TOUJEO MAX (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]24Current NDC, Legacy NDC, 4 package rows20250319_c9561d96-124d-48ca-982f-0aa1575bff36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1604539insulin glargine 300 UNT/ML in 1.5 ML Pen InjectorPSNc9561d96-124d-48ca-982f-0aa1575bff3625
2002419insulin glargine 300 UNT/ML in 3 ML Pen InjectorPSNc9561d96-124d-48ca-982f-0aa1575bff3625
1604544Toujeo 300 UNT/ML in 1.5 ML Pen InjectorPSNc9561d96-124d-48ca-982f-0aa1575bff3625
2002420Toujeo Max 300 UNT/ML in 3 ML Pen InjectorPSNc9561d96-124d-48ca-982f-0aa1575bff3625
16045441.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]SBDc9561d96-124d-48ca-982f-0aa1575bff3625
20024203 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]SBDc9561d96-124d-48ca-982f-0aa1575bff3625
16045391.5 ML insulin glargine 300 UNT/ML Pen InjectorSCDc9561d96-124d-48ca-982f-0aa1575bff3625
20024193 ML insulin glargine 300 UNT/ML Pen InjectorSCDc9561d96-124d-48ca-982f-0aa1575bff3625
16045441.5 ML Toujeo 300 UNT/ML Pen InjectorSYc9561d96-124d-48ca-982f-0aa1575bff3625
20024203 ML Toujeo 300 UNT/ML Pen InjectorSYc9561d96-124d-48ca-982f-0aa1575bff3625
1604539insulin glargine 300 UNT/ML per 1.5 ML Pen InjectorSYc9561d96-124d-48ca-982f-0aa1575bff3625
2002419insulin glargine 300 UNT/ML per 3 ML Pen InjectorSYc9561d96-124d-48ca-982f-0aa1575bff3625
1604544Toujeo 300 UNT/ML 1.5 ML Prefilled PenSYc9561d96-124d-48ca-982f-0aa1575bff3625
2002420Toujeo 300 UNT/ML per 3 ML Pen InjectorSYc9561d96-124d-48ca-982f-0aa1575bff3625
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
0024-5869-00000245869001 SYRINGE in 1 CARTON (0024-5869-00) / 1.5 mL in 1 SYRINGE1 syringe2015-02-150000-00-00YesNoCurrent
0024-5869-01000245869011.5 mL in 1 SYRINGE1.5 mlHistorical
0024-5869-03000245869033 SYRINGE in 1 CARTON (0024-5869-03) / 1.5 mL in 1 SYRINGE (0024-5869-01) 3 syringe2015-02-150000-00-00NoNoCurrent