Levemir

Product NDC
50090-1276
11-digit product format
500901276
Labeler code
50090
Product ID
50090-1276_f875f921-9dc6-4fca-8f9b-19485f41b3f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin detemir
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA021536
Marketing category
BLA
Marketing start
2006-03-27
Substance
INSULIN DETEMIR
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levemir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN DETEMIR100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4FT78T86XV
Rxcui484322, 616238, 847239, 847241

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1276-0Levemir1 in 1 CARTONINJECTION, SOLUTION124
50090-1276-0Levemir10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1276-0ML - Milliliter50090-1276c41e199c-1cf1-4056-a6ed-83580fb63e5c12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1276LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 2 package rows20241010_82192527-99aa-4b53-8ce9-9173668d309c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847239insulin detemir 100 UNT/ML in 3 ML Pen InjectorPSN82192527-99aa-4b53-8ce9-9173668d309c24
484322insulin detemir 100 UNT/ML Injectable SolutionPSN82192527-99aa-4b53-8ce9-9173668d309c24
847241Levemir 100 UNT/ML in 3 ML Pen InjectorPSN82192527-99aa-4b53-8ce9-9173668d309c24
616238Levemir 100 UNT/ML Injectable SolutionPSN82192527-99aa-4b53-8ce9-9173668d309c24
8472413 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]SBD82192527-99aa-4b53-8ce9-9173668d309c24
616238insulin detemir 100 UNT/ML Injectable Solution [Levemir]SBD82192527-99aa-4b53-8ce9-9173668d309c24
8472393 ML insulin detemir 100 UNT/ML Pen InjectorSCD82192527-99aa-4b53-8ce9-9173668d309c24
484322insulin detemir 100 UNT/ML Injectable SolutionSCD82192527-99aa-4b53-8ce9-9173668d309c24
8472413 ML Levemir 100 UNT/ML Pen InjectorSY82192527-99aa-4b53-8ce9-9173668d309c24
484322insulin analog, detemir 100 UNT/ML Injectable SolutionSY82192527-99aa-4b53-8ce9-9173668d309c24
847241Levemir 100 UNT/ML 3 ML FlexPenSY82192527-99aa-4b53-8ce9-9173668d309c24
847241Levemir 100 UNT/ML 3 ML FlexTouchSY82192527-99aa-4b53-8ce9-9173668d309c24
847241Levemir 100 UNT/ML 3 ML PenFillSY82192527-99aa-4b53-8ce9-9173668d309c24
616238Levemir 100 UNT/ML Injectable SolutionSY82192527-99aa-4b53-8ce9-9173668d309c24
616238Levemir 14.2 MG/ML Injectable SolutionSY82192527-99aa-4b53-8ce9-9173668d309c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1276-0500901276001 VIAL, GLASS in 1 CARTON (50090-1276-0) / 10 mL in 1 VIAL, GLASS2014-11-280000-00-00NoNoCurrent