Lantus

Product NDC
0088-5021
11-digit product format
000885021
Labeler code
0088
Product ID
0088-5021_7bfa39ee-1e03-4743-bf22-27cf983343c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
sanofi-aventis U.S. LLC
Application
BLA021081
Marketing category
BLA
Marketing start
2017-06-04
Marketing end
0000-00-00
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0088-5021-01ML - Milliliter0088-5021b0d181fb-2e3a-44de-b768-d9ccaf21004412017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0088-5021LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]20Legacy NDC20231201_6328c99d-d75f-43ef-b19e-7e71f91e57f6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0088-5021-01000885021011 VIAL, GLASS in 1 PACKAGE (0088-5021-01) > 10 mL in 1 VIAL, GLASS2017-06-040000-00-00NoNoCurrent