PRIALT
These highlights do not include all the information needed to use PRIALT safely and effectively. See full prescribing information for PRIALT.PRIALT (ziconotide) solution, intrathecal infusion Initial U.S. Approval: 2004
Approved
Approval ID
b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
TerSera Therapeutics LLC
DUNS: 080226115
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ziconotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70720-720
Application NumberNDA021060
Product Classification
M
Marketing Category
C73594
G
Generic Name
ziconotide acetate
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateAugust 15, 2019
FDA Product Classification
INGREDIENTS (3)
ziconotide acetateActive
Quantity: 100 ug in 1 mL
Code: T2I226K69M
Classification: ACTIM
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ziconotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70720-723
Application NumberNDA021060
Product Classification
M
Marketing Category
C73594
G
Generic Name
ziconotide acetate
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateAugust 15, 2019
FDA Product Classification
INGREDIENTS (3)
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ziconotide acetateActive
Quantity: 25 ug in 1 mL
Code: T2I226K69M
Classification: ACTIM
ziconotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70720-722
Application NumberNDA021060
Product Classification
M
Marketing Category
C73594
G
Generic Name
ziconotide acetate
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateAugust 15, 2019
FDA Product Classification
INGREDIENTS (3)
ziconotide acetateActive
Quantity: 100 ug in 1 mL
Code: T2I226K69M
Classification: ACTIM
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT