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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0169-6432		D	Discontinued by firm		2026-08-17
excluded package	package	0169-6432	0169-6432-10	D	Discontinued by firm		2026-08-17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0169-6432-10	Levemir	5 in 1 CARTON	INJECTION, SOLUTION	5		30
0169-6432-55	Levemir	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-6432-10	ML - Milliliter	0169-6432	b3b8b05f-c0f2-4aae-8a72-c7ec6c1bcdb9	1	2023-01-09
0169-6432-55	ML - Milliliter	0169-6432	919d936a-c88a-4fa3-a14a-788c293b89aa	1	2023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INSULIN DETEMIR	ACTIVE INGREDIENT	4FT78T86XV	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
INSULIN DETEMIR	ACTIVE MOIETY	4FT78T86XV	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
PHENOL	INACTIVE INGREDIENT	339NCG44TV	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-6432	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]	28	Current NDC, Legacy NDC, 2 package rows	20240605_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levemir	INSULIN DETEMIR	A-S Medication Solutions	82192527-99aa-4b53-8ce9-9173668d309c	2024-10-09	Warnings, Adverse reactions	Exact identifier application number: BLA021536
Levemir	INSULIN DETEMIR	Novo Nordisk	d38d65c1-25bf-401d-9c7e-a2c3222da8af	2022-12-08	Warnings, Adverse reactions	Exact identifier application number: BLA021536 ndc (product): 0169-6432

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
021536	Levemir	insulin detemir	351(a)	Disc	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4FT78T86XV	INSULIN DETEMIR	169148-63-4	INSULIN DETEMIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847239	insulin detemir 100 UNT/ML in 3 ML Pen Injector	PSN	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
484322	insulin detemir 100 UNT/ML Injectable Solution	PSN	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847241	Levemir 100 UNT/ML in 3 ML Pen Injector	PSN	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
616238	Levemir 100 UNT/ML Injectable Solution	PSN	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847241	3 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]	SBD	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
616238	insulin detemir 100 UNT/ML Injectable Solution [Levemir]	SBD	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847239	3 ML insulin detemir 100 UNT/ML Pen Injector	SCD	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
484322	insulin detemir 100 UNT/ML Injectable Solution	SCD	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847241	3 ML Levemir 100 UNT/ML Pen Injector	SY	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
484322	insulin analog, detemir 100 UNT/ML Injectable Solution	SY	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847241	Levemir 100 UNT/ML 3 ML FlexPen	SY	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847241	Levemir 100 UNT/ML 3 ML FlexTouch	SY	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847241	Levemir 100 UNT/ML 3 ML PenFill	SY	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
616238	Levemir 100 UNT/ML Injectable Solution	SY	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
616238	Levemir 14.2 MG/ML Injectable Solution	SY	d38d65c1-25bf-401d-9c7e-a2c3222da8af	30
847239	insulin detemir 100 UNT/ML in 3 ML Pen Injector	PSN	35e31793-9df4-4773-82b2-59678d8652bf	24
847239	insulin detemir 100 UNT/ML in 3 ML Pen Injector	PSN	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847241	Levemir 100 UNT/ML in 3 ML Pen Injector	PSN	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847241	Levemir 100 UNT/ML in 3 ML Pen Injector	PSN	35e31793-9df4-4773-82b2-59678d8652bf	24
847241	3 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]	SBD	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847241	3 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]	SBD	35e31793-9df4-4773-82b2-59678d8652bf	24
847239	3 ML insulin detemir 100 UNT/ML Pen Injector	SCD	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847239	3 ML insulin detemir 100 UNT/ML Pen Injector	SCD	35e31793-9df4-4773-82b2-59678d8652bf	24
847241	3 ML Levemir 100 UNT/ML Pen Injector	SY	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847241	3 ML Levemir 100 UNT/ML Pen Injector	SY	35e31793-9df4-4773-82b2-59678d8652bf	24
847241	Levemir 100 UNT/ML 3 ML FlexPen	SY	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847241	Levemir 100 UNT/ML 3 ML FlexPen	SY	35e31793-9df4-4773-82b2-59678d8652bf	24
847241	Levemir 100 UNT/ML 3 ML FlexTouch	SY	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847241	Levemir 100 UNT/ML 3 ML FlexTouch	SY	35e31793-9df4-4773-82b2-59678d8652bf	24
847241	Levemir 100 UNT/ML 3 ML PenFill	SY	9dc15d2d-e707-4014-9834-e202e8fc3089	24
847241	Levemir 100 UNT/ML 3 ML PenFill	SY	35e31793-9df4-4773-82b2-59678d8652bf	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0169-6432-10	00169643210	5 SYRINGE, PLASTIC in 1 CARTON (0169-6432-10) / 3 mL in 1 SYRINGE, PLASTIC (0169-6432-55)		2022-12-02	2026-06-30	No	No	Current
0169-6432-55	00169643255	3 mL in 1 SYRINGE, PLASTIC	3 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levemir	A-S Medication Solutions	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	24
LEVEMIR	A-S Medication Solutions	2023-03-12	HUMAN PRESCRIPTION DRUG LABEL	24
Levemir	Novo Nordisk	2022-12-08	HUMAN PRESCRIPTION DRUG LABEL	30