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NDC 00942-0641-03 ACD-A 3.65; 12.25; 11 g/500mL; g/500mL; g/500mL Details
ACD-A 3.65; 12.25; 11 g/500mL; g/500mL; g/500mL
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 | 00942-0641 |
|---|---|
| Product ID | 0942-0641_fc8f1ca0-251a-493a-ad8e-defe2a5c7141 |
| Associated GPIs | 83400030002020 |
| GCN Sequence Number | 062433 |
| GCN Sequence Number Description | dextrose/sod citrate/citric ac SOLUTION 2.45G-2.2G MISCELL |
| HIC3 | M9J |
| HIC3 Description | CITRATES AS ANTICOAGULANTS |
| GCN | 98209 |
| HICL Sequence Number | 015151 |
| HICL Sequence Number Description | DEXTROSE-WATER/SODIUM CITRATE/CITRIC ACID |
| Brand/Generic | Brand |
| Proprietary Name | ACD-A |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Anticoagulant Citrate Dextrose Solution Formula A |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 3.65; 12.25; 11 |
| Active Ingredient Units | g/500mL; g/500mL; g/500mL |
| 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 00942-0641-03 (00942064103)
| NDC Package Code | 0942-0641-03 |
|---|---|
| Billing NDC | 00942064103 |
| Package | 500 mL in 1 BAG (0942-0641-03) |
| Marketing Start Date | 2007-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 22805f0d-ba58-41ea-b245-19980abcda22 Details
Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A
CAUTION–
DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE
THE OVERWRAP IS A MOISTURE BARRIER
THE INNER BAG MAINTAINS THE STERILITY OF THE PRODUCT
STORE AT CONTROLLED ROOM TEMPERATURE
CODE 4B7898Q
NDC 0942-0641-03
500 mL
Fenwal™
Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A
EACH 100 mL CONTAINS 2.45 g DEXTROSE (MONOHYDRATE) USP 2.2 g SODIUM CITRATE (DIHYDRATE) USP 730 mg CITRIC ACID (ANHYDROUS) USP
STERILE , NONPYROGENIC
STERILIZED BY STEAM
SINGLE USE CONTAINER
DISCARD UNUSED PORTION
FOR USE WITH CYTAPHERESIS DEVICE ONLY
NOT FOR DIRECT INTRAVENOUS INFUSION
DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED
AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY
IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED
DISPOSE OF CONTAINER APPROPRIATELY
SEE CARTON FOR ADDITIONAL PRODUCT AND COUNTRY SPECIFIC INFORMATION
Rx only
PL 146 PLASTIC
Manufactured by:
Baxter Healthcare Corporation
65 Pitts Station Road
Marion, North Carolina 28752
MADE IN USA 07-25-57-867 REV: B
Manufactured for:
Fenwal, Inc.INGREDIENTS AND APPEARANCE
| ACD-A
anticoagulant citrate dextrose solution formula a solution |
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| Labeler - Fenwal, Inc. (794519020) |
| Registrant - Fenwal, Inc. (794519020) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Baxter Healthcare Corporation | 059140764 | MANUFACTURE(0942-0641) | |