FDA.reportPublic FDA data

Levemir

Product NDC
0169-6432
11-digit product format
001696432
Labeler code
0169
Product ID
0169-6432_f474a2c6-c2fe-4dec-86a9-7fc2aef980f3
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
2026-06-30
Substance
INSULIN DETEMIR
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levemir

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN DETEMIR100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4FT78T86XV
Rxcui484322, 616238, 847239, 847241

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-6432-10Levemir5 in 1 CARTONINJECTION, SOLUTION530
0169-6432-55Levemir3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION330

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-6432-10ML - Milliliter0169-6432b3b8b05f-c0f2-4aae-8a72-c7ec6c1bcdb912023-01-09
0169-6432-55ML - Milliliter0169-6432919d936a-c88a-4fa3-a14a-788c293b89aa12023-10-16

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
0169-6432LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]28Current NDC, Legacy NDC, 2 package rows20240605_d38d65c1-25bf-401d-9c7e-a2c3222da8af.zip

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 InjectorPSN35e31793-9df4-4773-82b2-59678d8652bf24
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
847241Levemir 100 UNT/ML in 3 ML Pen InjectorPSN35e31793-9df4-4773-82b2-59678d8652bf24
8472413 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]SBD9dc15d2d-e707-4014-9834-e202e8fc308924
8472413 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]SBD35e31793-9df4-4773-82b2-59678d8652bf24
8472393 ML insulin detemir 100 UNT/ML Pen InjectorSCD9dc15d2d-e707-4014-9834-e202e8fc308924
8472393 ML insulin detemir 100 UNT/ML Pen InjectorSCD35e31793-9df4-4773-82b2-59678d8652bf24
8472413 ML Levemir 100 UNT/ML Pen InjectorSY9dc15d2d-e707-4014-9834-e202e8fc308924
8472413 ML Levemir 100 UNT/ML Pen InjectorSY35e31793-9df4-4773-82b2-59678d8652bf24
847241Levemir 100 UNT/ML 3 ML FlexPenSY9dc15d2d-e707-4014-9834-e202e8fc308924
847241Levemir 100 UNT/ML 3 ML FlexPenSY35e31793-9df4-4773-82b2-59678d8652bf24
847241Levemir 100 UNT/ML 3 ML FlexTouchSY9dc15d2d-e707-4014-9834-e202e8fc308924
847241Levemir 100 UNT/ML 3 ML FlexTouchSY35e31793-9df4-4773-82b2-59678d8652bf24
847241Levemir 100 UNT/ML 3 ML PenFillSY9dc15d2d-e707-4014-9834-e202e8fc308924
847241Levemir 100 UNT/ML 3 ML PenFillSY35e31793-9df4-4773-82b2-59678d8652bf24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-6432-10001696432105 SYRINGE, PLASTIC in 1 CARTON (0169-6432-10) / 3 mL in 1 SYRINGE, PLASTIC (0169-6432-55) 2022-12-022026-06-30NoNoCurrent
0169-6432-55001696432553 mL in 1 SYRINGE, PLASTIC3 mlHistorical