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NDC 00942-9005-01 ACD-A 730; 2.45; 2.2 mg/100mL; g/100mL; g/100mL Details

ACD-A 730; 2.45; 2.2 mg/100mL; g/100mL; g/100mL

ACD-A is a INTRAVENOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fenwal, Inc.. The primary component is ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM.

Product Information

NDC	00942-9005
Product ID	0942-9005_26a93e4e-50c7-42d2-b169-c3ce9a89d106
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ACD-A
Proprietary Name Suffix	n/a
Non-Proprietary Name	Antiocoagulant Citrate Dextrose Solution, Formula A
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION
Route	INTRAVENOUS
Active Ingredient Strength	730; 2.45; 2.2
Active Ingredient Units	mg/100mL; g/100mL; g/100mL
Substance Name	ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM
Labeler Name	Fenwal, Inc.
Pharmaceutical Class	Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation F
DEA Schedule	n/a
Marketing Category	NDA
Application Number	BN160918
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00942-9005-01 (00942900501)

Pricing Information	N/A
NDC Package Code	0942-9005-01
Billing NDC	00942900501
Package	1000 mL in 1 BAG (0942-9005-01)
Marketing Start Date	2012-10-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bee8e967-496c-4541-b092-ead6c8c80269 Details

WARNINGS

Do Not Use Unless Solution is Clear and Seal is Intact

HOW SUPPLIED

Sterile, Non-pyrogenic

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACD-A

antiocoagulant citrate dextrose solution, formula a solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0942-9005
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.45 g in 100 mL
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE, UNSPECIFIED FORM	2.2 g in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	730 mg in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0942-9005-01	1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN160918	10/24/2012

Labeler - Fenwal, Inc. (794519020)

Registrant - Fenwal, Inc. (794519020)

Name	Address	ID/FEI	Business Operations
Establishment
Fenwal International, Inc.		091164590	MANUFACTURE(0942-9005)

Revised: 11/2022

Document Id: 26a93e4e-50c7-42d2-b169-c3ce9a89d106

Set id: bee8e967-496c-4541-b092-ead6c8c80269

Version: 9

Effective Time: 20221101