FDA.reportPublic FDA data

LANTUS SOLOSTAR

Product NDC
50090-4068
11-digit product format
500904068
Labeler code
50090
Product ID
50090-4068_0d876768-7216-4d1a-b54a-704989ec10bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA021081
Marketing category
BLA
Marketing start
2009-09-23
Substance
INSULIN GLARGINE
Active strength
100 [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
LANTUS SOLOSTAR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ
Rxcui847230, 847232

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4068-02023-02-07C16284748780-1f386c649-c9a6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS ® (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 2000
50090-4068-02023-01-30C16284748780-1f386c649-c9a6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS ® (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4068-0LANTUS SOLOSTAR5 in 1 CARTONINJECTION, SOLUTION56
50090-4068-0LANTUS SOLOSTAR3 mL in 1 SYRINGEINJECTION, SOLUTION36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4068-0ML - Milliliter50090-40685036f8ed-f391-4553-9183-0623192332e412022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4068LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20230723_3a97c40f-0c83-42d7-a8ee-484b208db4e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847230insulin glargine 100 UNT/ML in 3 ML Pen InjectorPSN3a97c40f-0c83-42d7-a8ee-484b208db4e36
847232Lantus 100 UNT/ML in 3 ML Pen InjectorPSN3a97c40f-0c83-42d7-a8ee-484b208db4e36
8472323 ML insulin glargine 100 UNT/ML Pen Injector [Lantus]SBD3a97c40f-0c83-42d7-a8ee-484b208db4e36
8472303 ML insulin glargine 100 UNT/ML Pen InjectorSCD3a97c40f-0c83-42d7-a8ee-484b208db4e36
8472303 ML insulin analog, glargine 100 UNT/ML Pen InjectorSY3a97c40f-0c83-42d7-a8ee-484b208db4e36
8472323 ML Lantus 100 UNT/ML Pen InjectorSY3a97c40f-0c83-42d7-a8ee-484b208db4e36
847230insulin analog, glargine 300 UNT Pen InjectorSY3a97c40f-0c83-42d7-a8ee-484b208db4e36
847230insulin glargine 300 UNT per 3 ML Pen InjectorSY3a97c40f-0c83-42d7-a8ee-484b208db4e36
847232Lantus 300 UNT per 3 ML OptiClik PenSY3a97c40f-0c83-42d7-a8ee-484b208db4e36
847232Lantus 300 UNT per 3 ML Pen InjectorSY3a97c40f-0c83-42d7-a8ee-484b208db4e36
847232Lantus 300 UNT per 3 ML SoloStar PenSY3a97c40f-0c83-42d7-a8ee-484b208db4e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4068-0500904068005 SYRINGE in 1 CARTON (50090-4068-0) / 3 mL in 1 SYRINGE5 syringe2019-01-170000-00-00NoNoCurrent