FDA.reportPublic FDA data

Lantus Solostar

Product NDC
50090-1398
11-digit product format
500901398
Labeler code
50090
Product ID
50090-1398_577365d4-f4cb-4431-9b05-a3d90efb7856
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 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
847230Internal RxNorm lookup
847232Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
632d9f68-f184-43d5-b184-a3af23f12ad9Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1398-02023-02-06C16284748780-1f386c649-b70b-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
50090-1398-02023-01-30C16284748780-1f386c649-b70b-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
50090-1398-0Lantus Solostar3 mL in 1 SYRINGEINJECTION, SOLUTION313
50090-1398-0Lantus Solostar5 in 1 PACKAGEINJECTION, SOLUTION513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1398-0ML - Milliliter50090-13989f291d21-7779-4f51-a87f-24dc235ad0b112018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1398LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20230608_632d9f68-f184-43d5-b184-a3af23f12ad9.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lantus SolostarINSULIN GLARGINEsanofi-aventis U.S. LLCd5e07a0c-7e14-4756-9152-9fea485d654a2025-06-02Warnings, Adverse reactionsExact identifier
application number: BLA021081
Insulin Glargine SolostarINSULIN GLARGINEA-S Medication Solutions9835904f-64f5-42b3-9ac9-89e4aaa5182a2023-11-01Warnings, Adverse reactionsExact identifier
application number: BLA021081
LANTUS SOLOSTARINSULIN GLARGINEA-S Medication Solutions3a97c40f-0c83-42d7-a8ee-484b208db4e32023-07-22Warnings, Adverse reactionsExact identifier
application number: BLA021081
Lantus SolostarINSULIN GLARGINEA-S Medication Solutions632d9f68-f184-43d5-b184-a3af23f12ad92023-06-06Warnings, Adverse reactionsExact identifier
application number: BLA021081
ndc (product): 50090-1398
LantusINSULIN GLARGINEA-S Medication Solutionsae27bb66-5dbe-4f01-a89e-f4fa7cb09c992023-02-04Warnings, Adverse reactionsExact identifier
application number: BLA021081

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021081Lantusinsulin glargine351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847230insulin glargine 100 UNT/ML in 3 ML Pen InjectorPSN632d9f68-f184-43d5-b184-a3af23f12ad913
847232Lantus 100 UNT/ML in 3 ML Pen InjectorPSN632d9f68-f184-43d5-b184-a3af23f12ad913
8472323 ML insulin glargine 100 UNT/ML Pen Injector [Lantus]SBD632d9f68-f184-43d5-b184-a3af23f12ad913
8472303 ML insulin glargine 100 UNT/ML Pen InjectorSCD632d9f68-f184-43d5-b184-a3af23f12ad913
8472303 ML insulin analog, glargine 100 UNT/ML Pen InjectorSY632d9f68-f184-43d5-b184-a3af23f12ad913
8472323 ML Lantus 100 UNT/ML Pen InjectorSY632d9f68-f184-43d5-b184-a3af23f12ad913
847230insulin analog, glargine 300 UNT Pen InjectorSY632d9f68-f184-43d5-b184-a3af23f12ad913
847230insulin glargine 300 UNT per 3 ML Pen InjectorSY632d9f68-f184-43d5-b184-a3af23f12ad913
847232Lantus 300 UNT per 3 ML OptiClik PenSY632d9f68-f184-43d5-b184-a3af23f12ad913
847232Lantus 300 UNT per 3 ML Pen InjectorSY632d9f68-f184-43d5-b184-a3af23f12ad913
847232Lantus 300 UNT per 3 ML SoloStar PenSY632d9f68-f184-43d5-b184-a3af23f12ad913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1398-0500901398005 SYRINGE in 1 PACKAGE (50090-1398-0) / 3 mL in 1 SYRINGE5 syringe2014-11-280000-00-00NoNoCurrent