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NDC 14537-0966-10 AS .03; .042; 1.1; .41; .588; .276 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Details
AS .03; .042; 1.1; .41; .588; .276 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
AS is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Terumo BCT Ltd. The primary component is ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM CITRATE, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE.
Product Information
| NDC | 14537-0966 |
|---|---|
| Product ID | 14537-966_1f7b74b9-e7df-41fc-9af6-cf7c340300f5 |
| 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 | AS |
| Proprietary Name Suffix | 3 |
| Non-Proprietary Name | Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | .03; .042; 1.1; .41; .588; .276 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL |
| Substance Name | ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM CITRATE, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
| Labeler Name | Terumo BCT Ltd |
| 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 | BN001214 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 14537-0966-10 (14537096610)
| NDC Package Code | 14537-966-10 |
|---|---|
| Billing NDC | 14537096610 |
| Package | 6 POUCH in 1 CASE (14537-966-10) / 6 BAG in 1 POUCH / 100 mL in 1 BAG |
| Marketing Start Date | 2002-05-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5f51ab45-2ff0-4b07-9fb9-69789da65d4b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Intended for use only with Trima and Trima Accel automated red blood cell apheresis devices and Atreus Whole Blood Processing System. See Operator's Manuals for additional information and complete usage instructions.
Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx only.
Single use container.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 100 mL Label
Additive Solution Formula 3 AS-3
Catalog # 777965-000
6 x 6 x 100 mL units
NDC 14537-966-10
Canada DIN 02324393
Intended for use only with Trima and Trima Accel automated red blood cell
apheresis devices and Atreus Whole Blood Processing System. See Operator's
Manuals for additional information and complete usage instructions.
Sterile. Non-pyrogenic. Do not use unless the solution is clear and
the container is intact. Rx only. Single use
container.
Caution: Not for direct intravenous infusion.
Recommended storage: Room temperature.
Avoid excessive heat. Protect from freezing.
Each 100 mL contains:
| Dextrose Monohydrate USP | 1.10 g |
| Sodium Citrate Dihydrate USP | 0.588 g |
| Sodium Chloride USP | 0.410 g |
| Monobasic Sodium Phosphate Monohydrate USP | 0.276 g |
| Citric Acid Monohydrate USP | 0.042 g |
| Adenine USP | 0.030 g |
| In Water for Injection USP |
Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA
Dist in Canada: Terumo BCT (Canada), Inc., 4 Robert Speck Pkwy,
Ste. 1500, Mississauga, ON, Canada L4Z1S1
TERUMOBCT
777965-065
Lot
Expiry Date
INGREDIENTS AND APPEARANCE
| AS
3
dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine injection, solution |
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| Labeler - Terumo BCT Ltd (233649834) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Terumo BCT Ltd. | 233649834 | MANUFACTURE(14537-966) , STERILIZE(14537-966) , LABEL(14537-966) , ANALYSIS(14537-966) | |