NDC 0942-9304 Cpda-1

Anticoagulant Citrate Phosphate Dextrose Adenine

NDC Product Code 0942-9304

NDC 0942-9304-03

Package Description: 63 mL in 1 BAG

NDC Product Information

Cpda-1 with NDC 0942-9304 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Cpda-1 is anticoagulant citrate phosphate dextrose adenine. The product's dosage form is solution and is administered via intravenous form.

Labeler Name: Fenwal, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cpda-1 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROSE MONOHYDRATE 2 g/63mL
  • TRISODIUM CITRATE DIHYDRATE 1.66 g/63mL
  • ANHYDROUS CITRIC ACID 188 mg/63mL
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 140 mg/63mL
  • ADENINE 17.3 mg/63mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Fenwal, Inc.
Labeler Code: 0942
FDA Application Number: BN770420 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2007 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cpda-1 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Instructions For Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, Usp (Cpda-1) Blood-Pack Units

  • Integral Donor Tube (IDT)Use aseptic technique.This product has components which contain natural rubber latex.Precaution: Do not use unless anticoagulant is clear.1.Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers.2.Adjust donor scale to desired collection weight.3.Position primary container on the donor scale as far as possible below donor arm and clamp donor tubing with hemostat.4.Apply pressure to donor’s arm and disinfect site of venipuncture.5.If blood pressure cuff is used, inflate to approximately 60 mmHg.6.Remove needle cover per instructions below:(a)Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.(b)Remove needle cover, being careful not to drag the cover across the needle point. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.7.Mix blood and anticoagulant at several intervals during collection and immediately after collection.8.Collect the appropriate volume based on Blood-Pack unit used. Note: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack unit ± 10%.9.Apply hemostat to donor tubing.10.As appropriate, release pressure on the donor’s arm, collect donor samples following established procedures and withdraw donor needle.Precaution: Use care to avoid accidental needle sticks. One of the Fenwal Needle Protector Systems may be used to reduce the risk of needle stick injury.11.Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.12.Discard needle into an appropriate biohazardous waste container following established procedures.13.Store suspended CPDA-1 Whole Blood/ Red Blood Cells between 1 and 6° C.14.Infuse CPDA-1 Whole Blood/Red Blood Cells within 35 days of collection.For further processing with multiple Blood-Pack units, use standard component processing techniques.Baxter Healthcare CorporationFenwal DivisionDeerfield, IL 60015 USAMade in USA07-19-29-257Iss. May 2002Baxter, Fenwal and Blood-Pack are trademarks of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

Package/Label Display Panel

  • Code 4R6312 20 UnitsBaxterFenwalAnticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack UnitTriple For the Collection and Processing of 450 mL BloodIntegral Donor Tube, 16 ga. Ultra Thin Wall NeedleEach unit consists of a PL 146 Plastic primary container with 63 mL of CPDA-1 solution containing 2 g Dextrose (monohydrate) USP, 1.66 g Sodium Citrate (dihydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP and 17.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; two empty 400 mL PL 1240 plastic Transfer Pack Containers.Rx onlySterile, nonpyrogenic fluid pathSee instructions for use.Store at room temperature. •Open pouch by tearing across at notch. •Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture. •Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth. •Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.U.S. Pat. Nos. 4,402,682; 4,413,992; 4,505,708; 4,508,534; 4,574,456; 5,314,421; 5,507,525.Baxter, Fenwal, Blood-Pack, PL 146 and Transfer Pack are trademarks of Baxter International Inc.; Baxter, Fenwal and Blood-Pack are registered in the U.S. Patent and Trademark Office.Baxter Healthcare CorporationFenwal DivisionDeerfield, IL 60015 USAMade in USA07-28-35-99602/2003

* Please review the disclaimer below.