Insulin Degludec

Product NDC: 73070-403
11-digit product format: 730700403
Labeler code: 73070
Product ID: 73070-403_c1be283d-4b1d-4996-b2a7-4488dbff3037
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin degludec
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Novo Nordisk Pharma, Inc.
Application: BLA203314
Marketing category: BLA
Marketing start: 2022-07-01
Marketing end: 2027-12-31
Substance: INSULIN DEGLUDEC
Active strength: 100 U/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Insulin Degludec

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INSULIN DEGLUDEC	100 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
54Q18076QB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1670011	Internal RxNorm lookup
1670021	Internal RxNorm lookup
2107520	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c1be283d-4b1d-4996-b2a7-4488dbff3037	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0dd952e2-ff48-4739-9b8d-72ae0b326834	Product name	2	20200323
34796cf9-f067-40c8-ac2d-d04e5b83ae05	Product name	2	20200323
6a6ef80c-37d6-4e02-aa78-fce7b811234e	Product name	2	20200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73070-403-15	Insulin Degludec	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3		1
73070-403-15	Insulin Degludec	5 in 1 CARTON	INJECTION, SOLUTION	5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73070-403-15	ML - Milliliter	73070-403	02acad58-0f5f-4a5b-bc5a-1a484b81b9d6	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73070-403	INSULIN DEGLUDEC INJECTION, SOLUTION [NOVO NORDISK PHARMA, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20220717_c1be283d-4b1d-4996-b2a7-4488dbff3037.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Insulin Degludec	INSULIN DEGLUDEC	A-S Medication Solutions	7a4bd8e5-7af4-4573-97c2-9945faf6a7dd	2024-06-03	Warnings, Adverse reactions	Exact identifier application number: BLA203314
Insulin Degludec	INSULIN DEGLUDEC	A-S Medication Solutions	62128c8b-f613-44d9-af04-18d52c4348cd	2024-05-31	Warnings, Adverse reactions	Exact identifier application number: BLA203314
TRESIBA	INSULIN DEGLUDEC	A-S Medication Solutions	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	2024-02-22	Warnings, Adverse reactions	Exact identifier application number: BLA203314
Tresiba	INSULIN DEGLUDEC	A-S Medication Solutions	84197351-cb71-4282-8217-13103404a2b4	2023-12-12	Warnings, Adverse reactions	Exact identifier application number: BLA203314
Insulin Degludec	INSULIN DEGLUDEC	Novo Nordisk Pharma, Inc.	c1be283d-4b1d-4996-b2a7-4488dbff3037	2022-07-01	Warnings, Adverse reactions	Exact identifier application number: BLA203314 ndc (product): 73070-403
Tresiba	INSULIN DEGLUDEC	Novo Nordisk	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	2022-07-01	Warnings, Adverse reactions	Exact identifier application number: BLA203314

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
203314	Tresiba	insulin degludec	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
54Q18076QB	INSULIN DEGLUDEC	844439-96-9	INSULIN DEGLUDEC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1670011	insulin degludec 100 UNT/ML in 3 ML Pen Injector	PSN	7a4bd8e5-7af4-4573-97c2-9945faf6a7dd	1
1670011	insulin degludec 100 UNT/ML in 3 ML Pen Injector	PSN	c1be283d-4b1d-4996-b2a7-4488dbff3037	1
2107520	insulin degludec 100 UNT/mL Injectable Solution	PSN	c1be283d-4b1d-4996-b2a7-4488dbff3037	1
1670021	insulin degludec 200 UNT/ML in 3 ML Pen Injector	PSN	c1be283d-4b1d-4996-b2a7-4488dbff3037	1
1670011	3 ML insulin degludec 100 UNT/ML Pen Injector	SCD	7a4bd8e5-7af4-4573-97c2-9945faf6a7dd	1
1670011	3 ML insulin degludec 100 UNT/ML Pen Injector	SCD	c1be283d-4b1d-4996-b2a7-4488dbff3037	1
1670021	3 ML insulin degludec 200 UNT/ML Pen Injector	SCD	c1be283d-4b1d-4996-b2a7-4488dbff3037	1
2107520	insulin degludec 100 UNT/ML Injectable Solution	SCD	c1be283d-4b1d-4996-b2a7-4488dbff3037	1
1670011	insulin degludec 100 UNT/ML per 3 ML Pen Injector	SY	7a4bd8e5-7af4-4573-97c2-9945faf6a7dd	1
1670011	insulin degludec 100 UNT/ML per 3 ML Pen Injector	SY	c1be283d-4b1d-4996-b2a7-4488dbff3037	1
1670021	insulin degludec 200 UNT/ML per 3 ML Pen Injector	SY	c1be283d-4b1d-4996-b2a7-4488dbff3037	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
73070-403-15	73070040315	5 SYRINGE, PLASTIC in 1 CARTON (73070-403-15) / 3 mL in 1 SYRINGE, PLASTIC	2022-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Insulin Degludec - A-S Medication Solutions	A-S Medication Solutions	2024-06-03	HUMAN PRESCRIPTION DRUG LABEL	1
Insulin Degludec	Novo Nordisk Pharma, Inc. \| Novo Nordisk A/S \| Novo Nordisk Pharmaceutical Industries, LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	2