NDC 0942-9206 Cpd

Anticoagulant Citrate Phosphate Dextrose (cpd)

NDC Product Code 0942-9206

NDC 0942-9206-01

Package Description: 63 mL in 1 BAG

NDC Product Information

Cpd with NDC 0942-9206 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Cpd is anticoagulant citrate phosphate dextrose (cpd). 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.

Cpd 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.

  • TRISODIUM CITRATE DIHYDRATE 1.66 g/63mL
  • DEXTROSE MONOHYDRATE 1.61 g/63mL
  • ANHYDROUS CITRIC ACID 188 mg/63mL
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 140 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: BN170401 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’.

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Cpd 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

Anticoagulant Citrate Phosphate Dextrose Solution, Usp (Cpd) Blood-Pack™ Unit For The Collection Of 450 Ml Of Whole Blood For Autologous Transfusion

  • Instructions for useUse aseptic technique:Rx onlyNotes: •For use with a 4C2498 Y-Type Connector set with Luer connector. If an alternate set is used, follow manufacturers instructions for use. •Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness. •Upon removal of Blood-Pack unit from the foil pouch, visually inspect the unit.Caution: Do not use unless solutions are clear. 1.Identify Blood-Pack unit using appropriate donor identification system for autologous transfusion. 2.Open package containing Y-Type Connector set. Close clamps. 3.Remove protector from the inlet tubing of the Blood-Pack unit(s). 4.Remove protector from the coupler on one lead of the set by slightly pushing on one side of the cap and then pulling the cap in a straight direction. Insert coupler into the inlet tubing of the Blood-Pack unit with a twisting motion until firmly seated. 5.Repeat step 4 with second Blood-Pack unit and the remaining lead on the Y-Type Connector set if a second unit is to be collected. 6.Prime the set with anticoagulant from one Blood-Pack unit by slowly opening clamp on one lead of the set to permit the solution to completely fill the set. Close clamp. 7.Place the Blood-Pack unit(s) in an inverted position below the level of the blood withdrawal site. 8.Attach lead with Luer connector to the arterial line, central venous pressure line, or peripheral venous line access. Provision should be made to replace the volume of blood collected either prior to or simultaneously with the collection in a manner prescribed by the attending physician.9.To begin collection, open the clamp on the patient access line and the lead that was used to prime the Y-Type Connector set. Collect 450 mL ± 10% of blood in the first Blood-Pack unit. Mix blood and anticoagulant solution while filling. Close clamp on the lead of the Y-Type Connector set.Note: •Use a scale or other appropriate means to ensure adequate collection of proper volume. 10.If a second unit is to be collected, open the clamp on the patient access line and the lead that was used to prime the Y-Type Connector set. Collect 450 mL ± 10% of blood in the second Blood-Pack unit. Mix blood and anticoagulant solution while filling. Close clamp on the lead of the Y-Type Connector set.Precaution: •Collection of the second unit should be initiated within approximately 4 minutes of collection of the first unit to avoid possible clot formation in the tubing. 11.Close or clamp the access line to prevent blood loss or air getting into the system or patient. Disconnect the Luer connector from the access line.Precaution: •Steps 12-15 should be performed within approximately 4 minutes after collection to avoid possible clot formation in the tubing. 12.If donor samples are desired, collect donor samples following established procedures. 13.Seal inlet tubing of the Blood-Pack unit(s). 14.If the inlet tubing is not sealed directly above the collection container, then strip the blood from the remaining inlet tubing into the collection container. Mix and allow tubing to refill; repeat once. Seal tubing at X marks on the inlet tubing and leave segments attached to the collection container. 15.Mix blood and anticoagulant solution, label and store in appropriate manner.Caution: This Blood-Pack unit is for autologous transfusion only. Blood collected should be stored at conditions appropriate for an autologous collection. Store at 1-6°C and reinfuse within 24 hours of collection.FENWAL and Blood-Pack are registered trademarks of Fenwal, Inc.Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USA07-19-54-238    Iss. 11/2007

Package/Label Display Panel

  • Code 4R04992 UnitsFenwal™Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ UnitSingle For Collection of 450 mL of Autologous BloodRx onlyEach unit consists of a PL 146 Plastic primary container with 63 mL of CPD solution containing 1.66 g Sodium Citrate (dihydrate) USP, 1.61 g Dextrose (monohydrate) USP, 188 mg Citric Acid (anhydrous) USP and 140 mg Monobasic Sodium Phosphate (monohydrate) USP. pH may have been adjusted with sodium hydroxide.Sterile, non-pyrogenic fluid path.See direction insert.Store at Controlled Room Temperature (refer to direction insert). •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.FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USA07-28-05-649 REV: A

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