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 Identifiers#

Field, Values table
Field	Values
Unii	54Q18076QB
Rxcui	1670011, 1670016, 1670021, 1670023, 2107520, 2107522

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

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

Tresiba

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#