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 Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ
Rxcui1604539, 2002419

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

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