FDA.reportPublic FDA data

Levemir

Product NDC
0169-6438
11-digit product format
001696438
Labeler code
0169
Product ID
0169-6438_40c85e9f-5e3e-4f53-a642-1ee982273108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin detemir
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0169-6438DDiscontinued by firm2026-08-17
excluded packagepackage0169-64380169-6438-10DDiscontinued by firm2026-08-17
excluded packagepackage0169-64380169-6438-97DDiscontinued by firm2026-08-17
excluded packagepackage0169-64380169-6438-98DDiscontinued 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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0169-6438-98d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0169-6438-97d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0169-6438-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0169-6438-98f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0169-6438-97f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0169-6438-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0169-6438-972ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0169-6438-982ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0169-6438-97a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0169-6438-98a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0169-6438-97cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0169-6438-98cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0169-6438-97cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0169-6438-98cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0169-6438-97302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0169-6438-98302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0169-6438-97ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0169-6438-98ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0169-6438-970efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0169-6438-980efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0169-6438-97ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0169-6438-98ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0169-6438-97367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0169-6438-98367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0169-6438-97557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0169-6438-98557ba5c1ecfa…9c80585c8c6e…

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-6438-10Levemir3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION330
0169-6438-10Levemir5 in 1 CARTONINJECTION, SOLUTION530
0169-6438-90Levemir3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION330
0169-6438-97Levemir1 in 1 CARTONINJECTION, SOLUTION130
0169-6438-98Levemir1 in 1 CARTONINJECTION, SOLUTION130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-6438-10ML - Milliliter0169-6438dd498b74-9e97-4db1-b51e-f60f19cc35cf12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN DETEMIRACTIVE INGREDIENT4FT78T86XVLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
INSULIN DETEMIRACTIVE MOIETY4FT78T86XVLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
METACRESOLINACTIVE INGREDIENTGGO4Y809LOLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
PHENOLINACTIVE INGREDIENT339NCG44TVLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
ZINCINACTIVE INGREDIENTJ41CSQ7QDSLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-6438LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]28Legacy NDC, 5 package rows20240605_d38d65c1-25bf-401d-9c7e-a2c3222da8af.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
ndc (product): 0169-6438

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 InjectorPSNd38d65c1-25bf-401d-9c7e-a2c3222da8af30
484322insulin detemir 100 UNT/ML Injectable SolutionPSNd38d65c1-25bf-401d-9c7e-a2c3222da8af30
847241Levemir 100 UNT/ML in 3 ML Pen InjectorPSNd38d65c1-25bf-401d-9c7e-a2c3222da8af30
616238Levemir 100 UNT/ML Injectable SolutionPSNd38d65c1-25bf-401d-9c7e-a2c3222da8af30
8472413 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]SBDd38d65c1-25bf-401d-9c7e-a2c3222da8af30
616238insulin detemir 100 UNT/ML Injectable Solution [Levemir]SBDd38d65c1-25bf-401d-9c7e-a2c3222da8af30
8472393 ML insulin detemir 100 UNT/ML Pen InjectorSCDd38d65c1-25bf-401d-9c7e-a2c3222da8af30
484322insulin detemir 100 UNT/ML Injectable SolutionSCDd38d65c1-25bf-401d-9c7e-a2c3222da8af30
8472413 ML Levemir 100 UNT/ML Pen InjectorSYd38d65c1-25bf-401d-9c7e-a2c3222da8af30
484322insulin analog, detemir 100 UNT/ML Injectable SolutionSYd38d65c1-25bf-401d-9c7e-a2c3222da8af30
847241Levemir 100 UNT/ML 3 ML FlexPenSYd38d65c1-25bf-401d-9c7e-a2c3222da8af30
847241Levemir 100 UNT/ML 3 ML FlexTouchSYd38d65c1-25bf-401d-9c7e-a2c3222da8af30
847241Levemir 100 UNT/ML 3 ML PenFillSYd38d65c1-25bf-401d-9c7e-a2c3222da8af30
616238Levemir 100 UNT/ML Injectable SolutionSYd38d65c1-25bf-401d-9c7e-a2c3222da8af30
616238Levemir 14.2 MG/ML Injectable SolutionSYd38d65c1-25bf-401d-9c7e-a2c3222da8af30
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-6438-10001696438105 SYRINGE, PLASTIC in 1 CARTON (0169-6438-10) > 3 mL in 1 SYRINGE, PLASTIC2013-10-310000-00-00NoNoCurrent
0169-6438-90001696438903 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-6438-97001696438971 in 1 CARTONHistorical
0169-6438-98001696438981 SYRINGE, PLASTIC in 1 CARTON (0169-6438-98) > 3 mL in 1 SYRINGE, PLASTIC (0169-6438-90) 2013-10-310000-00-00NoNoCurrent