FDA.reportPublic FDA data

Insulin glargine U-300 Max

Product NDC
0955-2900
11-digit product format
009552900
Labeler code
0955
Product ID
0955-2900_63c52b96-0bdf-42f0-9c6c-e439846e6926
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
2023-04-01
Substance
INSULIN GLARGINE
Active strength
300 [iU]/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
Insulin glargine U-300 Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE300 [iU]/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
1604539Internal RxNorm lookup
2002419Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99ea856d-9562-443a-9422-1006a3cff2f4Available 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
0955-2900-01Insulin glargine U-300 Max3 mL in 1 SYRINGEINJECTION, SOLUTION37
0955-2900-02Insulin glargine U-300 Max2 in 1 CARTONINJECTION, SOLUTION27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-2900-01ML - Milliliter0955-2900d5f1116f-3b0d-4a22-b902-789dc1133f5512024-02-14
0955-2900-02ML - Milliliter0955-29006dda0158-cc5b-4530-884a-73ea65000a7e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-2900INSULIN GLARGINE U-300 (INSULIN GLARGINE) INJECTION, SOLUTION INSULIN GLARGINE U-300 MAX (INSULIN GLARGINE) INJECTION, SOLUTION [WINTHROP U.S.]6Current NDC, 2 package rows20240913_99ea856d-9562-443a-9422-1006a3cff2f4.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
ndc (product): 0955-2900
TOUJEO MaxINSULIN GLARGINEA-S Medication Solutions620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab92023-07-12Warnings, Adverse reactionsExact identifier
application number: BLA206538
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
1604539insulin glargine 300 UNT/ML in 1.5 ML Pen InjectorPSN99ea856d-9562-443a-9422-1006a3cff2f47
2002419insulin glargine 300 UNT/ML in 3 ML Pen InjectorPSN99ea856d-9562-443a-9422-1006a3cff2f47
16045391.5 ML insulin glargine 300 UNT/ML Pen InjectorSCD99ea856d-9562-443a-9422-1006a3cff2f47
20024193 ML insulin glargine 300 UNT/ML Pen InjectorSCD99ea856d-9562-443a-9422-1006a3cff2f47
1604539insulin glargine 300 UNT/ML per 1.5 ML Pen InjectorSY99ea856d-9562-443a-9422-1006a3cff2f47
2002419insulin glargine 300 UNT/ML per 3 ML Pen InjectorSY99ea856d-9562-443a-9422-1006a3cff2f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0955-2900-01009552900013 mL in 1 SYRINGE3 mlHistorical
0955-2900-02009552900022 SYRINGE in 1 CARTON (0955-2900-02) / 3 mL in 1 SYRINGE (0955-2900-01) 2 syringe2023-04-01NoNoCurrent