FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4FT78T86XVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
484322Internal RxNorm lookup
616238Internal RxNorm lookup
847239Internal RxNorm lookup
847241Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82192527-99aa-4b53-8ce9-9173668d309cAvailable on FDA.report

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

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
LevemirINSULIN DETEMIRA-S Medication Solutions82192527-99aa-4b53-8ce9-9173668d309c2024-10-09Warnings, Adverse reactionsExact identifier
application number: BLA021536
ndc (product): 50090-1276
LevemirINSULIN DETEMIRNovo Nordiskd38d65c1-25bf-401d-9c7e-a2c3222da8af2022-12-08Warnings, Adverse reactionsExact identifier
application number: BLA021536

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021536Levemirinsulin detemir351(a)Disc2026-07-01

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