ACD-A
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Approved
Approval ID
22805f0d-ba58-41ea-b245-19980abcda22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 11, 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 Dextrose Solution Formula A
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0942-0641
Application NumberBN160918
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Dextrose Solution Formula A
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (4)
Dextrose MonohydrateActive
Quantity: 12.25 g in 500 mL
Code: LX22YL083G
Classification: ACTIB
Anhydrous Citric AcidActive
Quantity: 3.65 g in 500 mL
Code: XF417D3PSL
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMActive
Quantity: 11 g in 500 mL
Code: 1Q73Q2JULR
Classification: ACTIB