Sodium Citrate Blood-Pack Units, (PL 146 Plastic)
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Approved
Approval ID
14b238ab-904b-45dc-9eb9-a1074364e089
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 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 Sodium Citrate Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0942-9506
Application NumberBN770923
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Sodium Citrate Solution
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 7, 2022
FDA Product Classification
INGREDIENTS (2)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 4 g in 100 mL
Code: B22547B95K
Classification: ACTIM