BASAGLAR

Product NDC
0002-8214
Requested package NDC
0002-8214-05
11-digit product format
000028214
Labeler code
0002
Product ID
0002-8214_3c2283e6-2844-44d2-a447-579b07e77c27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin glargine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA205692
Marketing category
BLA
Marketing start
2015-12-16
Marketing end
2026-07-27
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0002-82140002-8214-05DDiscontinued by firm2026-08-17

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8214-01BASAGLAR Tempo Pen3 mL in 1 SYRINGEINJECTION, SOLUTION334
0002-8214-05BASAGLAR Tempo Pen5 in 1 CARTONINJECTION, SOLUTION534

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8214-01ML - Milliliter0002-82147fd3f859-a424-483f-afeb-40a889949b5312022-12-07
0002-8214-05ML - Milliliter0002-821496a02779-1c08-4c9d-9d09-68482da5bb0812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8214BASAGLAR KWIKPEN (INSULIN GLARGINE) INJECTION, SOLUTION BASAGLAR TEMPO PEN (INSULIN GLARGINE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]33Current NDC, Legacy NDC, 2 package rows20231214_0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BASAGLAR KwikPenINSULIN GLARGINEEli Lilly and Company0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae2026-06-16Warnings, Adverse reactionsExact identifier
application number: BLA205692
ndc (package): 0002-8214-05
ndc (product): 0002-8214
ndc11 (package): 00002821405

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
205692Basaglarinsulin glargine351(a)Disc2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736863Basaglar KwikPen 100 UNT/ML in 3 ML Pen InjectorPSN0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268065Basaglar Tempo 100 UNT/ML in 3 ML Pen InjectorPSN0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
847230insulin glargine 100 UNT/ML in 3 ML Pen InjectorPSN0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268064insulin glargine 100 UNT/ML in 3 ML Pen Injector with SensorPSN0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
17368633 ML insulin glargine 100 UNT/ML Pen Injector [Basaglar]SBD0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268065Sensor 3 ML insulin glargine 100 UNT/ML Pen Injector [Basaglar]SBD0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
8472303 ML insulin glargine 100 UNT/ML Pen InjectorSCD0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268064Sensor 3 ML insulin glargine 100 UNT/ML Pen InjectorSCD0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
17368633 ML Basaglar 100 UNT/ML Pen InjectorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
8472303 ML insulin analog, glargine 100 UNT/ML Pen InjectorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268065Basaglar 100 UNT/ML per 3 ML Pen Injector with SensorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
1736863Basaglar 300 UNT per 3 ML Pen InjectorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268065Basaglar 300 UNT per 3 ML Pen Injector with SensorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
847230insulin analog, glargine 300 UNT Pen InjectorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268064insulin glargine 100 UNT/ML per 3 ML Pen Injector with SensorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
847230insulin glargine 300 UNT per 3 ML Pen InjectorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34
2268064insulin glargine 300 UNT per 3 ML Pen Injector with SensorSY0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8214-05000028214055 SYRINGE in 1 CARTON (0002-8214-05) / 3 mL in 1 SYRINGE (0002-8214-01) 5 syringe2019-11-152026-07-27NoNoCurrent