KINEVAC
These highlights do not include all the information needed to use KINEVAC safely and effectively. See full prescribing information for KINEVACKINEVAC (sincalide for injection), for intravenous use Initial U.S. Approval: 1976
Approved
Approval ID
1408aabb-6982-48e5-ae9f-504ec43b0003
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Bracco Diagnostics Inc.
DUNS: 849234661
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sincalide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-0556
Application NumberNDA017697
Product Classification
M
Marketing Category
C73594
G
Generic Name
sincalide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2018
FDA Product Classification
INGREDIENTS (8)
SincalideActive
Quantity: 5 ug in 5 mL
Code: M03GIQ7Z6P
Classification: ACTIB
mannitolInactive
Quantity: 170 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
potassium phosphate, dibasicInactive
Quantity: 9 mg in 5 mL
Code: CI71S98N1Z
Classification: IACT
methionineInactive
Quantity: 4 mg in 5 mL
Code: AE28F7PNPL
Classification: IACT
arginine hydrochlorideInactive
Quantity: 30 mg in 5 mL
Code: F7LTH1E20Y
Classification: IACT
sodium metabisulfiteInactive
Quantity: 0.04 mg in 5 mL
Code: 4VON5FNS3C
Classification: IACT
lysine hydrochlorideInactive
Quantity: 15 mg in 5 mL
Code: JNJ23Q2COM
Classification: IACT
polysorbate 20Inactive
Quantity: 0.005 ug in 5 mL
Code: 7T1F30V5YH
Classification: IACT