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 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
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

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