Lantus

Product NDC
50090-0876
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 Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ
Rxcui285018, 311041

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#

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

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