NDC 0942-6336 Cpda-1

Anticoagulant Citrate Phosphate Dextrose Adenine

NDC Product Code 0942-6336

NDC 0942-6336-03

Package Description: 63 mL in 1 BAG

NDC Product Information

Cpda-1 with NDC 0942-6336 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 2.01 g/63mL
  • TRISODIUM CITRATE DIHYDRATE 1.66 g/63mL
  • CITRIC ACID MONOHYDRATE 206 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: 06-21-2010 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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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 (Cpda-1) Blood-Pack™ Unit

  • Rx OnlyIntegral Donor Tube (IDT)Use aseptic technique.Caution: Do not use unless the solutions are clear.1.Identify BLOOD-PACK™ unit using appropriate donor identification system.2.Adjust donor scale to desired collection weight/volume.3.Suspend primary container from donor scale as far as possible below donor arm and clamp donor tubing at Position 1 (see Figure 1). Use one of the clamps that come inside the aluminum pouch.4.Apply pressure to donor’s arm and disinfect site of venipuncture.5.If blood pressure cuff is used, inflate to approximately 60 mm Hg.6.Remove needle cover per instructions below:a)Hold the needle hub upwards. With the other hand, grasp the base of the needle cover (Figure 2), twist approximately 1/4 turn to break tamper evident seal (Figure 3).b)Remove needle cover (Figure 4), be careful not to drag cover across the needle point (Figure 5).7.Perform venipuncture, appropriately secure donor needle and/or tubing and move clamp to Position 2 (Figure 1).8.Mix blood and anticoagulant at several intervals during collection and immediately after collection.9.Collect labeled volume of blood. Anticoagulant volume is sufficient for labeled volume ± 10%.10.Place clamp back to Position 1 (Figure 1).11.Seal donor tubing between clamp and primary container (a hand sealer clamp may be used). Dispose of needle and tubing appropriately. Cut between clamp and clip/seal; collect any needed samples using standard techniques.12.Release pressure on donor’s arm and withdraw needle.13.Strip blood from donor tubing into 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.14.Store suspended Red Blood Cells between 1 and 6°C.15.Infuse suspended Red Blood Cells within 35 days of collection.NOTE:In order to establish fluid transfer from primary container to secondary system, hold the cannula by its base with one hand, and with the other hand break the cannula by bending it 90º in one direction, then 180º in the opposite direction (Figure 6).For further processing, use standard component processing and storage techniques.Dispose of containers and materials into appropriate biohazardous waste containers following established procedures.Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only.Store at Controlled Room Temperature.USP Definition of “Controlled Room Temperature”United States Pharmacopeia, General Notices.United States Pharmacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MDManufacturerManufactured by:Fenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606Made in USAImported and distributed in India by:Fenwal India Pvt LtdUpper Ground Floor, Tower BDLF Building No. 10, DLF Cyber CityDLF Phase-II, Gurgaon 122 002,Haryana, IndiaImport License No.: FF-504-14890Imported and distributed in Indonesia by:PT.Medquest Jaya GlobalMenara Salemba 6th FloorJl.Salemba Raya Kav 5-5AJakarta-Indonesia 10440Reg. No.: DEPKES RI AKL 20209902358Imported and distributed in Thailand by:Fenwal (Thailand) Ltd.17th Fl. Thanapoom Tower,1550 New Petchburi Rd., MakasanRajthevi, Bangkok 10400ThailandImported and distributed in Venezuela by:SOLUCARE GT, C.A. RIF J-30512494-9en La Urbina, Caracas,Republica Bolivariana de VenezuelaTELF (0212) 2436663Registrado en el MPPS bajo el No:07-19-07-227 REV: A 05/2012FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.© 2012 Fenwal, Inc. All rights reserved.

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