FDA.reportPublic FDA data

Lantus

Product NDC
50090-0876
Requested package NDC
50090-0876-0
11-digit product format
500900876
Labeler code
50090
Product ID
50090-0876_36965dca-e4e9-465f-a209-bb5f76739989
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
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
285018Internal RxNorm lookup
311041Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99Available 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
50090-0876-02023-02-07C16284748780-1f386c64a-47fd-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
50090-0876-02023-01-30C16284748780-1f386c64a-47fd-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
50090-0876-0Lantus10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0876-0ML - Milliliter50090-0876fb57822b-68f7-4f83-a1b2-18ef20bb9d6612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0876LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 1 package rows20230208_ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99.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
LantusINSULIN GLARGINEA-S Medication Solutionsae27bb66-5dbe-4f01-a89e-f4fa7cb09c992023-02-04Warnings, Adverse reactionsExact identifier
application number: BLA021081
ndc (package): 50090-0876-0
ndc (product): 50090-0876
ndc11 (package): 50090087600

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021081Lantusinsulin glargine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311041insulin glargine 100 UNT/ML Injectable SolutionPSNae27bb66-5dbe-4f01-a89e-f4fa7cb09c9912
285018Lantus 100 UNT/ML Injectable SolutionPSNae27bb66-5dbe-4f01-a89e-f4fa7cb09c9912
285018insulin glargine 100 UNT/ML Injectable Solution [Lantus]SBDae27bb66-5dbe-4f01-a89e-f4fa7cb09c9912
311041insulin glargine 100 UNT/ML Injectable SolutionSCDae27bb66-5dbe-4f01-a89e-f4fa7cb09c9912
311041insulin analog, glargine 100 UNT/ML Injectable SolutionSYae27bb66-5dbe-4f01-a89e-f4fa7cb09c9912
285018Lantus 100 UNT/ML Injectable SolutionSYae27bb66-5dbe-4f01-a89e-f4fa7cb09c9912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0876-05009008760010 mL in 1 VIAL, GLASS (50090-0876-0) 10 ml2014-11-280000-00-00NoNoCurrent