FDA.reportPublic FDA data

LEVEMIR

Product NDC
50090-6391
11-digit product format
500906391
Labeler code
50090
Product ID
50090-6391_9736dfc4-160a-4df2-8524-4419fea3403b
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-6391DDiscontinued by firm2026-08-17
excluded packagepackage50090-639150090-6391-0DDiscontinued by firm2026-08-17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6391-0LEVEMIR3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION324
50090-6391-0LEVEMIR5 in 1 CARTONINJECTION, SOLUTION524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6391-0ML - Milliliter50090-63919318ee9a-c5a4-46ea-b1e3-f4d674d23e7012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6391LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]24Current NDC, 2 package rows20230317_35e31793-9df4-4773-82b2-59678d8652bf.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
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 InjectorPSN35e31793-9df4-4773-82b2-59678d8652bf24
847241Levemir 100 UNT/ML in 3 ML Pen InjectorPSN35e31793-9df4-4773-82b2-59678d8652bf24
8472413 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]SBD35e31793-9df4-4773-82b2-59678d8652bf24
8472393 ML insulin detemir 100 UNT/ML Pen InjectorSCD35e31793-9df4-4773-82b2-59678d8652bf24
8472413 ML Levemir 100 UNT/ML Pen InjectorSY35e31793-9df4-4773-82b2-59678d8652bf24
847241Levemir 100 UNT/ML 3 ML FlexPenSY35e31793-9df4-4773-82b2-59678d8652bf24
847241Levemir 100 UNT/ML 3 ML FlexTouchSY35e31793-9df4-4773-82b2-59678d8652bf24
847241Levemir 100 UNT/ML 3 ML PenFillSY35e31793-9df4-4773-82b2-59678d8652bf24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6391-0500906391005 SYRINGE, PLASTIC in 1 CARTON (50090-6391-0) / 3 mL in 1 SYRINGE, PLASTIC2023-03-09NoNoHistorical