sogroya

Generic: somapacitan-beco

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name sogroya
Generic Name somapacitan-beco
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

somapacitan 3.3 mg/mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-2035
Product ID 0169-2035_8927dc8b-9804-4136-8eb4-3576283659ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761156
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01692035
Hyphenated Format 0169-2035

Supplemental Identifiers

RxCUI
2557398 2557403 2571802 2571805 2636951 2636954
UNII
8FOJ430U94

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sogroya (source: ndc)
Generic Name somapacitan-beco (source: ndc)
Application Number BLA761156 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.3 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-11) / 1.5 mL in 1 SYRINGE, PLASTIC
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-90) / 1.5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (2)

0169-2035-11 1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-11) / 1.5 mL in 1 SYRINGE, PLASTIC 0169-2035-90 1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-90) / 1.5 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

somapacitan (3.3 mg/mL)

Linked Drug Pages (1)

SOGROYA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8927dc8b-9804-4136-8eb4-3576283659ac", "openfda": {"unii": ["8FOJ430U94"], "rxcui": ["2557398", "2557403", "2571802", "2571805", "2636951", "2636954"], "spl_set_id": ["eadd03b4-adc3-4b88-8a24-9d205c5b85aa"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-11)  / 1.5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0169-2035-11", "marketing_start_date": "20230501"}, {"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2035-90)  / 1.5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0169-2035-90", "marketing_start_date": "20230501"}], "brand_name": "SOGROYA", "product_id": "0169-2035_8927dc8b-9804-4136-8eb4-3576283659ac", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0169-2035", "generic_name": "somapacitan-beco", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOGROYA", "active_ingredients": [{"name": "SOMAPACITAN", "strength": "3.3 mg/mL"}], "application_number": "BLA761156", "marketing_category": "BLA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}