SOGROYA

Product NDC: 0169-2037
11-digit product format: 001692037
Labeler code: 0169
Product ID: 0169-2037_02935ecf-5395-4b9b-9b2f-75d59ca651f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: somapacitan-beco
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Novo Nordisk
Application: BLA761156
Marketing category: BLA
Marketing start: 2023-05-01
Substance: SOMAPACITAN
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: SOGROYA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SOMAPACITAN	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8FOJ430U94	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2557398	Internal RxNorm lookup
2557403	Internal RxNorm lookup
2571802	Internal RxNorm lookup
2571805	Internal RxNorm lookup
2636951	Internal RxNorm lookup
2636954	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
eadd03b4-adc3-4b88-8a24-9d205c5b85aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3db24f33-28f1-4bf1-b5d1-be169942b92a	Product name	3	20240507
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0169-2037-11	SOGROYA	1.5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	1.5	8
0169-2037-11	SOGROYA	1 in 1 CARTON	INJECTION, SOLUTION	1	8
0169-2037-90	SOGROYA	1 in 1 CARTON	INJECTION, SOLUTION	1	8
0169-2037-90	SOGROYA	1.5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	1.5	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-2037-11	ML - Milliliter	0169-2037	889c9dbb-e8fc-491e-a376-bccd5e680bf4	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-2037	SOGROYA (SOMAPACITAN-BECO) INJECTION, SOLUTION [NOVO NORDISK]	6	Current NDC, 4 package rows	20250215_eadd03b4-adc3-4b88-8a24-9d205c5b85aa.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOGROYA	SOMAPACITAN-BECO	Novo Nordisk	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	2026-02-25	Warnings, Adverse reactions	Exact identifier application number: BLA761156 ndc (product): 0169-2037

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761156	Sogroya	somapacitan-beco	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8FOJ430U94	SOMAPACITAN	1338578-34-9	SOMAPACITAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2557403	Sogroya 10 MG in 1.5 ML Pen Injector	PSN	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2636954	Sogroya 15 MG in 1.5 ML Pen Injector	PSN	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571805	Sogroya 5 MG in 1.5 ML Pen Injector	PSN	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2557398	somapacitan-beco 10 MG in 1.5 ML Pen Injector	PSN	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2636951	somapacitan-beco 15 MG in 1.5 ML Pen Injector	PSN	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571802	somapacitan-beco 5 MG in 1.5 ML Pen Injector	PSN	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2636954	1.5 ML somapacitan-beco 10 MG/ML Pen Injector [Sogroya]	SBD	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571805	1.5 ML somapacitan-beco 3.3 MG/ML Pen Injector [Sogroya]	SBD	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2557403	1.5 ML somapacitan-beco 6.7 MG/ML Pen Injector [Sogroya]	SBD	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2636951	1.5 ML somapacitan-beco 10 MG/ML Pen Injector	SCD	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571802	1.5 ML somapacitan-beco 3.3 MG/ML Pen Injector	SCD	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2557398	1.5 ML somapacitan-beco 6.7 MG/ML Pen Injector	SCD	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2636954	1.5 ML Sogroya 10 MG/ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2557403	1.5 ML Sogroya 6.7 MG/ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2557403	Sogroya 10 MG per 1.5 ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2636954	Sogroya 15 MG per 1.5 ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571805	Sogroya 3.3 MG/ML per 1.5 ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571805	Sogroya 5 MG per 1.5 ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2636951	somapacitan-beco 15 MG per 1.5 ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571802	somapacitan-beco 3.3 MG/ML per 1.5 ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8
2571802	somapacitan-beco 5 MG per 1.5 ML Pen Injector	SY	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0169-2037-11	00169203711	1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-11) / 1.5 mL in 1 SYRINGE, PLASTIC	2023-05-01	No	No	Current
0169-2037-90	00169203790	1 SYRINGE, PLASTIC in 1 CARTON (0169-2037-90) / 1.5 mL in 1 SYRINGE, PLASTIC	2023-05-01	No	No	Current