Tresiba

Product NDC: 0169-2550
11-digit product format: 001692550
Labeler code: 0169
Product ID: 0169-2550_e5571110-ca7e-4fcc-88a8-9f1d0104c508
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin degludec
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Novo Nordisk
Application: BLA203314
Marketing category: BLA
Marketing start: 2015-09-25
Substance: INSULIN DEGLUDEC
Active strength: 200 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: Tresiba
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INSULIN DEGLUDEC	200 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1670011	Internal RxNorm lookup
1670016	Internal RxNorm lookup
1670021	Internal RxNorm lookup
1670023	Internal RxNorm lookup
2107520	Internal RxNorm lookup
2107522	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
456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	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	SPL version
0169-2550-13	Tresiba	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	14
0169-2550-13	Tresiba	3 in 1 CARTON	INJECTION, SOLUTION	3	14
0169-2550-90	Tresiba	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	14
0169-2550-97	Tresiba	1 in 1 CARTON	INJECTION, SOLUTION	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-2550-13	ML - Milliliter	0169-2550	74eeacd9-02e6-4089-9c94-59fbc886e32c	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INSULIN DEGLUDEC	ACTIVE INGREDIENT	54Q18076QB	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
INSULIN DEGLUDEC	ACTIVE MOIETY	54Q18076QB	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	TRESIBA (INSULIN DEGLUDEC INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-2550	TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [NOVO NORDISK]	14	Current NDC, Legacy NDC, 4 package rows	20220720_456c5e87-3dfd-46fa-8ac0-c6128d4c97c6.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
Tresiba	INSULIN DEGLUDEC	Novo Nordisk	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	2022-07-01	Warnings, Adverse reactions	Exact identifier application number: BLA203314 ndc (product): 0169-2550

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	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
2107520	insulin degludec 100 UNT/mL Injectable Solution	PSN	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670021	insulin degludec 200 UNT/ML in 3 ML Pen Injector	PSN	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670016	Tresiba 100 UNT/ML in 3 ML Pen Injector	PSN	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
2107522	Tresiba 100 UNT/mL Injectable Solution	PSN	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670023	Tresiba 200 UNT/ML in 3 ML Pen Injector	PSN	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670016	3 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba]	SBD	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670023	3 ML insulin degludec 200 UNT/ML Pen Injector [Tresiba]	SBD	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
2107522	insulin degludec 100 UNT/ML Injectable Solution [Tresiba]	SBD	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670011	3 ML insulin degludec 100 UNT/ML Pen Injector	SCD	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670021	3 ML insulin degludec 200 UNT/ML Pen Injector	SCD	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
2107520	insulin degludec 100 UNT/ML Injectable Solution	SCD	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670016	3 ML Tresiba 100 UNT/ML Pen Injector	SY	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670023	3 ML Tresiba 200 UNT/ML Pen Injector	SY	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670011	insulin degludec 100 UNT/ML per 3 ML Pen Injector	SY	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670021	insulin degludec 200 UNT/ML per 3 ML Pen Injector	SY	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
2107522	Tresiba 100 UNT/ML Injectable Solution	SY	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670016	Tresiba 100 UNT/ML per 3 ML Pen Injector	SY	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670023	Tresiba 200 UNT/ML per 3 ML Pen Injector	SY	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	14
1670021	insulin degludec 200 UNT/ML in 3 ML Pen Injector	PSN	84197351-cb71-4282-8217-13103404a2b4	11
1670023	Tresiba 200 UNT/ML in 3 ML Pen Injector	PSN	84197351-cb71-4282-8217-13103404a2b4	11
1670023	3 ML insulin degludec 200 UNT/ML Pen Injector [Tresiba]	SBD	84197351-cb71-4282-8217-13103404a2b4	11
1670021	3 ML insulin degludec 200 UNT/ML Pen Injector	SCD	84197351-cb71-4282-8217-13103404a2b4	11
1670023	3 ML Tresiba 200 UNT/ML Pen Injector	SY	84197351-cb71-4282-8217-13103404a2b4	11
1670021	insulin degludec 200 UNT/ML per 3 ML Pen Injector	SY	84197351-cb71-4282-8217-13103404a2b4	11
1670023	Tresiba 200 UNT/ML per 3 ML Pen Injector	SY	84197351-cb71-4282-8217-13103404a2b4	11
1670021	insulin degludec 200 UNT/ML in 3 ML Pen Injector	PSN	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	1
1670023	Tresiba 200 UNT/ML in 3 ML Pen Injector	PSN	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	1
1670023	3 ML insulin degludec 200 UNT/ML Pen Injector [Tresiba]	SBD	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	1
1670021	3 ML insulin degludec 200 UNT/ML Pen Injector	SCD	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	1
1670023	3 ML Tresiba 200 UNT/ML Pen Injector	SY	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	1
1670021	insulin degludec 200 UNT/ML per 3 ML Pen Injector	SY	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	1
1670023	Tresiba 200 UNT/ML per 3 ML Pen Injector	SY	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0169-2550-13	00169255013	3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13) / 3 mL in 1 SYRINGE, PLASTIC		2015-09-25	0000-00-00	No	No	Current
0169-2550-90	00169255090	3 mL in 1 SYRINGE, PLASTIC	3 ml					Historical
0169-2550-97	00169255097	1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-2550-90)		2015-09-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRESIBA	A-S Medication Solutions	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	1
Tresiba	A-S Medication Solutions	2023-12-12	HUMAN PRESCRIPTION DRUG LABEL	11
Tresiba	Novo Nordisk	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	14