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NDC 14537-0967-75 ACD .8; 2.45; 2.2 g/100mL; g/100mL; g/100mL Details
ACD .8; 2.45; 2.2 g/100mL; g/100mL; g/100mL
ACD is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Terumo BCT Ltd. The primary component is CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM.
Product Information
| NDC | 14537-0967 |
|---|---|
| Product ID | 14537-967_75f7d630-1735-4761-a42a-5c5687a021bd |
| Associated GPIs | 83400030002020 |
| GCN Sequence Number | 079367 |
| GCN Sequence Number Description | dextrose/sod citrate/citric ac SOLUTION 2.45G-2.2G MISCELL |
| HIC3 | M9J |
| HIC3 Description | CITRATES AS ANTICOAGULANTS |
| GCN | 45859 |
| HICL Sequence Number | 015151 |
| HICL Sequence Number Description | DEXTROSE-WATER/SODIUM CITRATE/CITRIC ACID |
| Brand/Generic | Brand |
| Proprietary Name | ACD |
| Proprietary Name Suffix | A |
| Non-Proprietary Name | Dextrose Monohydrate, Sodium Citrate, and Citric Acid Monohydrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | .8; 2.45; 2.2 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL |
| Substance Name | CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM |
| Labeler Name | Terumo BCT Ltd |
| Pharmaceutical Class | Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorpti |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | BA010228 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 14537-0967-75 (14537096775)
| NDC Package Code | 14537-967-75 |
|---|---|
| Billing NDC | 14537096775 |
| Package | 12 BAG in 1 CASE (14537-967-75) / 750 mL in 1 BAG |
| Marketing Start Date | 2002-02-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 570770de-9b48-4fc1-a1ee-06002ca9504f Details
SPL UNCLASSIFIED SECTION
Recommended storage
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 12 Bag Case Label
Anticoagulant Citrate Dextrose
Solution USP (ACD) Solution A
Catalog # 40800
12 x 750 mL units
NDC 14537-967-75
Sterile. Non-pyrogenic. Do not use unless the solution is clear
and the container is intact. Rx Only. Single use container.
For use only with apheresis devices. See apheresis device
operator's manual for complete instructions.
Caution: Not for direct intravenous infusion.
Recommended storage: Store up to 25 °C. (See USP
Controlled Room Temperature).
Avoid excessive heat. Protect from freezing.
Each 100 mL contains:
Dextrose Monohydrate USP 2.45 g
Sodium Citrate Dihydrate USP 2.20 g
Citric Acid Monohydrate USP 0.80 g
In Water for Injection USP
Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA
777967-066
TERUMOBCT
Lot
Expiry Date
INGREDIENTS AND APPEARANCE
| ACD
A
dextrose monohydrate, sodium citrate, and citric acid monohydrate injection, solution |
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| Labeler - Terumo BCT Ltd (233649834) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Terumo BCT Ltd. | 233649834 | MANUFACTURE(14537-967) , STERILIZE(14537-967) , LABEL(14537-967) , ANALYSIS(14537-967) | |