Levemir

Product NDC: 50090-1475
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-1475		D	Discontinued by firm		2026-08-17
excluded package	package	50090-1475	50090-1475-0	D	Discontinued by firm		2026-08-17

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1475-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1475-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1475-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1475-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1475-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1475-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1475-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1475-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1475-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-1475-0	`ad56d346431e…`	`cc804d4bbf1e…`

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1475-0	Levemir	5 in 1 CARTON	INJECTION, SOLUTION	5		24
50090-1475-0	Levemir	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1475-0	ML - Milliliter	50090-1475	8cd1ea72-842d-40fa-881a-20c57935f029	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1475	LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	24	Legacy NDC, 2 package rows	20241010_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
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 ndc (product): 50090-1475
Levemir	INSULIN DETEMIR	Novo Nordisk	d38d65c1-25bf-401d-9c7e-a2c3222da8af	2022-12-08	Warnings, Adverse reactions	Exact identifier application number: BLA021536

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	82192527-99aa-4b53-8ce9-9173668d309c	24
484322	insulin detemir 100 UNT/ML Injectable Solution	PSN	82192527-99aa-4b53-8ce9-9173668d309c	24
847241	Levemir 100 UNT/ML in 3 ML Pen Injector	PSN	82192527-99aa-4b53-8ce9-9173668d309c	24
616238	Levemir 100 UNT/ML Injectable Solution	PSN	82192527-99aa-4b53-8ce9-9173668d309c	24
847241	3 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]	SBD	82192527-99aa-4b53-8ce9-9173668d309c	24
616238	insulin detemir 100 UNT/ML Injectable Solution [Levemir]	SBD	82192527-99aa-4b53-8ce9-9173668d309c	24
847239	3 ML insulin detemir 100 UNT/ML Pen Injector	SCD	82192527-99aa-4b53-8ce9-9173668d309c	24
484322	insulin detemir 100 UNT/ML Injectable Solution	SCD	82192527-99aa-4b53-8ce9-9173668d309c	24
847241	3 ML Levemir 100 UNT/ML Pen Injector	SY	82192527-99aa-4b53-8ce9-9173668d309c	24
484322	insulin analog, detemir 100 UNT/ML Injectable Solution	SY	82192527-99aa-4b53-8ce9-9173668d309c	24
847241	Levemir 100 UNT/ML 3 ML FlexPen	SY	82192527-99aa-4b53-8ce9-9173668d309c	24
847241	Levemir 100 UNT/ML 3 ML FlexTouch	SY	82192527-99aa-4b53-8ce9-9173668d309c	24
847241	Levemir 100 UNT/ML 3 ML PenFill	SY	82192527-99aa-4b53-8ce9-9173668d309c	24
616238	Levemir 100 UNT/ML Injectable Solution	SY	82192527-99aa-4b53-8ce9-9173668d309c	24
616238	Levemir 14.2 MG/ML Injectable Solution	SY	82192527-99aa-4b53-8ce9-9173668d309c	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1475-0	50090147500	5 SYRINGE, PLASTIC in 1 CARTON (50090-1475-0) > 3 mL in 1 SYRINGE, PLASTIC	2014-11-28	0000-00-00	No	No	Current