FDA.reportPublic FDA data

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 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
2589008Internal RxNorm lookup
2589014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6af8706-2058-4fe1-99c8-43684c20bfa2Available 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

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8980-01ML - Milliliter0002-8980adaf4ef0-9f3c-4183-9dba-575e8b82d4a712024-11-05
0002-8980-05ML - Milliliter0002-898020369b3b-37de-45eb-9677-ab6bf9dc3a7112023-04-07

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rezvoglar KwikPenINSULIN GLARGINE-AGLREli Lilly and Companyf6af8706-2058-4fe1-99c8-43684c20bfa22024-08-09Warnings, Adverse reactionsExact identifier
application number: BLA761215
ndc (product): 0002-8980
REZVOGLAR KWIKPENINSULIN GLARGINE-AGLRA-S Medication Solutions78888c87-7155-4e81-954d-cb40822ee27b2023-05-02Warnings, Adverse reactionsExact identifier
application number: BLA761215

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761215Rezvoglarinsulin glargine-aglr351(k) InterchangeableRx2026-07-01

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