NDC 0942-6329 Cpda-1

Anticoagulant Citrate Phosphate Dextrose Adenine

NDC Product Code 0942-6329

NDC 0942-6329-03

Package Description: 49 mL in 1 BAG

NDC Product Information

Cpda-1 with NDC 0942-6329 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.

  • ADENINE 13.5 mg/49mL

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: 05-25-2010 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

Anticoagulant Citrate Phosphate Dextrose Adenine Solution (Cpda-1) Blood-Pack™ Unit

  • Rx onlyIntegral Donor Tube (IDT).Use aseptic technique.Caution: Do not use unless anticoagulant is clear. 1.Identify BLOOD-PACK™ unit using appropriate donor identification system.2.Adjust donor scale to desired collection/weight/volume.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 mm Hg.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. 7.Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.8.Mix blood and anticoagulant at several intervals during collection and immediately after collection.9.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%.10.Apply hemostat to donor tubing.11.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. A Needle Protector System may be used to reduce the risk of needle stick injury.12.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.13.Discard needle into an appropriate biohazardous waste container following established procedures.14.Store suspended CPDA-1 whole blood/red blood cells between 1 and 6ºC. 15.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.Definition of Symbols: ManufacturerDispose of container appropriately.Single use only.Do not use if there is any visible sign of deterioration.Do not vent.Sterilized by steam. Sterile fluid path.Non-pyrogenic fluid path.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, MD Manufactured by:Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USAFenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606Imported 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-504-14890FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.07-19-04-284 REV: A01/2010© 2010 Fenwal, Inc. All rights reserved.

Package/Label Display Panel

REF R4R76346 UnitsFenwal™Triple BLOOD-PACK™ UnitAnticoagulant Citrate PhosphateDextrose Adenine Solution (CPDA-1)PL 146 PlasticRx onlyTriple BLOOD-PACK™ unit consisting of a primary pack containing 49 mL of CPDA-1 anticoagulant solution and two transfer packs without solution for collection of 350 mL of blood, 16 gauge needle.See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is any visible evidence of deterioration. Dispose of container appropriately. Store at Controlled Room Temperature (refer to direction insert). Unused packs in open foil pouch may be kept 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 pack may result in mold growth.Each 49 mL CPDA-1 solution contains 1.56 g Dextrose (monohydrate), USP, 1.29 g Sodium Citrate (dihydrate), USP, 160 mg Citric Acid (monohydrate), USP, 109 mg Monobasic Sodium Phosphate (monohydrate), USP, 13.5 mg Adenine, USP, Water for Injection USP to 49 mL.Manufactured by: Fenwal International, Inc.oad 357, Km. 0.8aricao, PR 00606 Made In USAImported and distributed in Indonesia by: PT.Medquest Jaya Global Menara Salemba 6th Floor Jl.Salemba Raya Kav 5-5A Jakarta-Indonesia 10440 Reg. No.: See Instructions for use. Imported 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-504-14890MRP: Rs. 239 (inclusive of all taxes)FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.PL 146 is a trademark of Baxter International, Inc.07-28-04-287 REV: A

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