Isoplate

Basic Information

Product Name

Isoplate

FDA Product Code

14537-408

Regulatory Information

NDC Product Code

14537-408

Application Number

BN090067

Marketing Category

C73594

Effective Date

May 8, 2015

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POTASSIUM CHLORIDE

Quantity: 0.037 g in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

SODIUM ACETATE

Quantity: 0.37 g in 100 mL

Code: 4550K0SC9B

Class Code: ACTIB

SODIUM GLUCONATE

Quantity: 0.5 g in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 0.53 g in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

Quantity: 0.008 g in 100 mL

Code: GR686LBA74

Class Code: ACTIB

POTASSIUM PHOSPHATE, MONOBASIC

Quantity: 0.00082 g in 100 mL

Code: 4J9FJ0HL51

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

MAGNESIUM CHLORIDE

Quantity: 0.03 g in 100 mL

Code: 02F3473H9O

Class Code: ACTIB

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

SODIUM CATION

Code: LYR4M0NH37

POTASSIUM CATION

Code: 295O53K152

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

Active Moieties

CHLORIDE ION

SODIUM CATION

POTASSIUM CATION