Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit
Approved
Approval ID
d55cb701-9664-4931-8754-1a8cae68da06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2022
Manufacturers
FDA
Fenwal, Inc.
DUNS: 794519020
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0942-9201
Application NumberBN170401
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEActive
Quantity: 893 mg in 35 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDActive
Quantity: 105 mg in 35 mL
Code: XF417D3PSL
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 78 mg in 35 mL
Code: 593YOG76RN
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 921 mg in 35 mL
Code: B22547B95K
Classification: ACTIM