Rezvoglar

Product NDC
0002-8980
11-digit product format
000028980
Labeler code
0002
Product ID
0002-8980_a9e95b4c-e280-4bef-a3dd-4907bfad6b4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin glargine-aglr
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA761215
Marketing category
BLA
Marketing start
2021-12-17
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
Rezvoglar
Brand name suffix
KwikPen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ
Rxcui2589008, 2589014

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
0002-8980-01Rezvoglar KwikPen3 mL in 1 SYRINGEINJECTION, SOLUTION37
0002-8980-05Rezvoglar KwikPen5 in 1 CARTONINJECTION, SOLUTION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8980REZVOGLAR KWIKPEN (INSULIN GLARGINE-AGLR) INJECTION, SOLUTION [ELI LILLY AND COMPANY]7Current NDC, Legacy NDC, 2 package rows20240817_f6af8706-2058-4fe1-99c8-43684c20bfa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2589008insulin glargine-aglr 300 UNT in 3 ML Pen InjectorPSNf6af8706-2058-4fe1-99c8-43684c20bfa27
2589014REZVOGLAR (insulin glargine-aglr) 100 UNT/ML in 3 ML Pen InjectorPSNf6af8706-2058-4fe1-99c8-43684c20bfa27
25890143 ML insulin glargine-aglr 100 UNT/ML Pen Injector [Rezvoglar]SBDf6af8706-2058-4fe1-99c8-43684c20bfa27
25890083 ML insulin glargine-aglr 100 UNT/ML Pen InjectorSCDf6af8706-2058-4fe1-99c8-43684c20bfa27
25890143 ML Rezvoglar 100 UNT/ML Pen InjectorSYf6af8706-2058-4fe1-99c8-43684c20bfa27
2589008insulin glargine-aglr 300 UNT per 3 ML Pen InjectorSYf6af8706-2058-4fe1-99c8-43684c20bfa27
2589014Rezvoglar KwikPen (insulin glargine-aglr) 300 UNT per 3 ML Pen InjectorSYf6af8706-2058-4fe1-99c8-43684c20bfa27
2589008insulin glargine-aglr 300 UNT in 3 ML Pen InjectorPSN78888c87-7155-4e81-954d-cb40822ee27b1
2589014REZVOGLAR (insulin glargine-aglr) 100 UNT/ML in 3 ML Pen InjectorPSN78888c87-7155-4e81-954d-cb40822ee27b1
25890143 ML insulin glargine-aglr 100 UNT/ML Pen Injector [Rezvoglar]SBD78888c87-7155-4e81-954d-cb40822ee27b1
25890083 ML insulin glargine-aglr 100 UNT/ML Pen InjectorSCD78888c87-7155-4e81-954d-cb40822ee27b1
25890143 ML Rezvoglar 100 UNT/ML Pen InjectorSY78888c87-7155-4e81-954d-cb40822ee27b1
2589008insulin glargine-aglr 300 UNT per 3 ML Pen InjectorSY78888c87-7155-4e81-954d-cb40822ee27b1
2589014Rezvoglar KwikPen (insulin glargine-aglr) 300 UNT per 3 ML Pen InjectorSY78888c87-7155-4e81-954d-cb40822ee27b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8980-01000028980013 mL in 1 SYRINGE3 mlHistorical
0002-8980-05000028980055 SYRINGE in 1 CARTON (0002-8980-05) / 3 mL in 1 SYRINGE (0002-8980-01) 5 syringe2021-12-170000-00-00NoNoCurrent