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Tresiba

These highlights do not include all the information needed to use TRESIBA safely and effectively. See full prescribing information for TRESIBA. TRESIBA (insulin degludec) injection, for subcutaneous useInitial U.S. Approval: 2015

Approved
Approval ID

84197351-cb71-4282-8217-13103404a2b4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

insulin degludec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-3491
Application NumberBLA203314
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin degludec
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 1, 2022
FDA Product Classification

INGREDIENTS (8)

GLYCERINInactive
Quantity: 19.6 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
INSULIN DEGLUDECActive
Quantity: 200 U in 1 mL
Code: 54Q18076QB
Classification: ACTIB
ZINCInactive
Quantity: 71.9 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
PHENOLInactive
Quantity: 1.50 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Tresiba - FDA Drug Approval Details