FDA.reportPublic FDA data

Levemir

Product NDC
0169-3687
11-digit product format
001693687
Labeler code
0169
Product ID
0169-3687_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
2006-03-27
Marketing end
2026-08-31
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
0169-3687-12Levemir1 in 1 CARTONINJECTION, SOLUTION130
0169-3687-12Levemir10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1030
0169-3687-92Levemir10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1030
0169-3687-92Levemir1 in 1 CARTONINJECTION, SOLUTION130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3687-12ML - Milliliter0169-368780088ef1-44c3-43ec-9d35-10d7b57ff55d12012-07-24

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
INSULIN DETEMIRACTIVE INGREDIENT4FT78T86XVLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
INSULIN DETEMIRACTIVE MOIETY4FT78T86XVLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
METACRESOLINACTIVE INGREDIENTGGO4Y809LOLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
PHENOLINACTIVE INGREDIENT339NCG44TVLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1
ZINCINACTIVE INGREDIENTJ41CSQ7QDSLEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3687LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]28Current NDC, Legacy NDC, 4 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 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
484322insulin detemir 100 UNT/ML Injectable SolutionPSN2b8d9730-686b-444b-9941-7b58772559241
616238Levemir 100 UNT/ML Injectable SolutionPSN2b8d9730-686b-444b-9941-7b58772559241
616238insulin detemir 100 UNT/ML Injectable Solution [Levemir]SBD2b8d9730-686b-444b-9941-7b58772559241
484322insulin detemir 100 UNT/ML Injectable SolutionSCD2b8d9730-686b-444b-9941-7b58772559241
484322insulin analog, detemir 100 UNT/ML Injectable SolutionSY2b8d9730-686b-444b-9941-7b58772559241
616238Levemir 100 UNT/ML Injectable SolutionSY2b8d9730-686b-444b-9941-7b58772559241
616238Levemir 14.2 MG/ML Injectable SolutionSY2b8d9730-686b-444b-9941-7b58772559241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0169-3687-12001693687121 VIAL, GLASS in 1 CARTON (0169-3687-12) / 10 mL in 1 VIAL, GLASS2006-03-272026-08-31NoNoCurrent
0169-3687-92001693687921 VIAL, GLASS in 1 CARTON (0169-3687-92) > 10 mL in 1 VIAL, GLASS2006-03-272022-09-30NoNoCurrent