Nutricel Additive System - CP2D
CP2D/AS-3 Blood Collection and Sampling System
Approved
Approval ID
6c5cf2fb-8f57-496e-b756-dfbfba07b516
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2012
Manufacturers
FDA
Medsep Corporation
DUNS: 928224765
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CP2D/AS-3 Anticoagulant and Additive System
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62646-120
Application NumberNDA820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
CP2D/AS-3 Anticoagulant and Additive System
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2012
FDA Product Classification
INGREDIENTS (4)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 0.155 g in 70 mL
Code: 593YOG76RN
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 3.57 g in 70 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CITRATEActive
Quantity: 1.84 g in 70 mL
Code: 1Q73Q2JULR
Classification: ACTIB
CITRIC ACID MONOHYDRATEActive
Quantity: 0.229 g in 70 mL
Code: 2968PHW8QP
Classification: ACTIB
CP2D/AS-3 Anticoagulant and Additive System
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62646-AS3
Application NumberNDA820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
CP2D/AS-3 Anticoagulant and Additive System
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2012
FDA Product Classification
INGREDIENTS (6)
SODIUM CITRATEActive
Quantity: 0.647 g in 110 mL
Code: 1Q73Q2JULR
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 0.304 g in 110 mL
Code: 593YOG76RN
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 1.21 g in 110 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.451 g in 110 mL
Code: 451W47IQ8X
Classification: ACTIB
CITRIC ACID MONOHYDRATEActive
Quantity: 0.046 g in 110 mL
Code: 2968PHW8QP
Classification: ACTIB
ADENINEActive
Quantity: 0.033 g in 110 mL
Code: JAC85A2161
Classification: ACTIB