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
4a08a9ec-46a5-4fcf-80ee-5c33f1a8b746
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)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0942-9202
Application NumberBN170401
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Dextrose (CPD)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEActive
Quantity: 1.61 g in 63 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDActive
Quantity: 188 mg in 63 mL
Code: XF417D3PSL
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 140 mg in 63 mL
Code: 593YOG76RN
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 1.66 g in 63 mL
Code: B22547B95K
Classification: ACTIM