FDA.reportPublic FDA data

REZVOGLAR KWIKPEN

Product NDC
50090-6439
11-digit product format
500906439
Labeler code
50090
Product ID
50090-6439_68a9b7e3-8bf4-4e52-a853-9b30b906e314
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin glargine-aglr
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
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 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
78888c87-7155-4e81-954d-cb40822ee27bAvailable 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
50090-6439-0REZVOGLAR KWIKPEN3 mL in 1 SYRINGEINJECTION, SOLUTION31
50090-6439-0REZVOGLAR KWIKPEN5 in 1 CARTONINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6439-0ML - Milliliter50090-643942de0fad-0aa9-4e11-83e2-32abefcd10d212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6439REZVOGLAR KWIKPEN (INSULIN GLARGINE-AGLR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230504_78888c87-7155-4e81-954d-cb40822ee27b.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
REZVOGLAR KWIKPENINSULIN GLARGINE-AGLRA-S Medication Solutions78888c87-7155-4e81-954d-cb40822ee27b2023-05-02Warnings, Adverse reactionsExact identifier
application number: BLA761215
ndc (product): 50090-6439

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 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 startSampleExclude flagStatus
50090-6439-0500906439005 SYRINGE in 1 CARTON (50090-6439-0) / 3 mL in 1 SYRINGE5 syringe2023-04-17NoNoCurrent