FDA.reportPublic FDA data

Levemir

Product NDC
50090-1475
Requested package NDC
50090-1475-0
11-digit product format
500901475
Labeler code
50090
Product ID
50090-1475_2c52048f-d704-426f-9737-104af6f013c3
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
Marketing end
0000-00-00
Substance
INSULIN DETEMIR
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-147550090-1475-0DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1475-0Levemir5 in 1 CARTONINJECTION, SOLUTION524
50090-1475-0Levemir3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1475-0ML - Milliliter50090-14758cd1ea72-842d-40fa-881a-20c57935f02912018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1475LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]24Legacy 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 (package): 50090-1475-0
ndc (product): 50090-1475
ndc11 (package): 50090147500
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
50090-1475-0500901475005 SYRINGE, PLASTIC in 1 CARTON (50090-1475-0) > 3 mL in 1 SYRINGE, PLASTIC2014-11-280000-00-00NoNoCurrent