Isoplate
These highlights do not include all the information needed to use ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] safely and effectively. See full prescribing information for ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F]. ISOPLATE SOLUTION Platelet Additive Solution [PAS-F] Sterile Fluid Polyolefin Bag Initial U.S. Approval: 2013
Approved
Approval ID
37932532-4fbf-4485-abe6-d2c9f9fc3b80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2018
Manufacturers
FDA
Terumo BCT Ltd.
DUNS: 233649834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE, MONOBASIC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14537-408
Application NumberBN090067
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE, MONOBASIC
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 8, 2015
FDA Product Classification
INGREDIENTS (8)
POTASSIUM CHLORIDEActive
Quantity: 0.037 g in 100 mL
Code: 660YQ98I10
Classification: ACTIB
SODIUM ACETATEActive
Quantity: 0.37 g in 100 mL
Code: 4550K0SC9B
Classification: ACTIB
SODIUM GLUCONATEActive
Quantity: 0.5 g in 100 mL
Code: R6Q3791S76
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.53 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMActive
Quantity: 0.008 g in 100 mL
Code: GR686LBA74
Classification: ACTIB
POTASSIUM PHOSPHATE, MONOBASICActive
Quantity: 0.00082 g in 100 mL
Code: 4J9FJ0HL51
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM CHLORIDEActive
Quantity: 0.03 g in 100 mL
Code: 02F3473H9O
Classification: ACTIB