Levemir

Product NDC
50090-6414
11-digit product format
500906414
Labeler code
50090
Product ID
50090-6414_23c59a01-2db9-474a-b262-eed752dc8470
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
2013-10-31
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
Rxcui847239, 847241

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6414-0Levemir3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION324
50090-6414-0Levemir5 in 1 CARTONINJECTION, SOLUTION524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6414-0ML - Milliliter50090-641441f3418c-b3f2-4d28-8a6f-e33983a3267112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6414LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]24Current NDC, 2 package rows20230504_9dc15d2d-e707-4014-9834-e202e8fc3089.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847239insulin detemir 100 UNT/ML in 3 ML Pen InjectorPSN9dc15d2d-e707-4014-9834-e202e8fc308924
847241Levemir 100 UNT/ML in 3 ML Pen InjectorPSN9dc15d2d-e707-4014-9834-e202e8fc308924
8472413 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]SBD9dc15d2d-e707-4014-9834-e202e8fc308924
8472393 ML insulin detemir 100 UNT/ML Pen InjectorSCD9dc15d2d-e707-4014-9834-e202e8fc308924
8472413 ML Levemir 100 UNT/ML Pen InjectorSY9dc15d2d-e707-4014-9834-e202e8fc308924
847241Levemir 100 UNT/ML 3 ML FlexPenSY9dc15d2d-e707-4014-9834-e202e8fc308924
847241Levemir 100 UNT/ML 3 ML FlexTouchSY9dc15d2d-e707-4014-9834-e202e8fc308924
847241Levemir 100 UNT/ML 3 ML PenFillSY9dc15d2d-e707-4014-9834-e202e8fc308924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6414-0500906414005 SYRINGE, PLASTIC in 1 CARTON (50090-6414-0) / 3 mL in 1 SYRINGE, PLASTIC2023-03-29NoNoHistorical