CPDA-1
Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) BLOOD-PACK™ Unit
Approved
Approval ID
f9d7f1b4-7a77-44f9-8924-10b16008b49d
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 Adenine (CPDA-1) Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0942-9394
Application NumberBN770420
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (6)
DEXTROSE MONOHYDRATEActive
Quantity: 2 g in 63 mL
Code: LX22YL083G
Classification: ACTIB
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ADENINEActive
Quantity: 17.3 mg in 63 mL
Code: JAC85A2161
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 1.66 g in 63 mL
Code: B22547B95K
Classification: ACTIM