NDC 0942-9202 Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic

Anticoagulant Citrate Phosphate Dextrose (cpd)

NDC Product Code 0942-9202

NDC Code: 0942-9202

Proprietary Name: Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Anticoagulant Citrate Phosphate Dextrose (cpd) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0942 - Fenwal, Inc.
    • 0942-9202 - Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic

NDC 0942-9202-01

Package Description: 63 mL in 1 BAG

NDC Product Information

Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic with NDC 0942-9202 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic 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.

Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic 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

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: 03-31-2007 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: 12-31-2020 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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Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic 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 Solution, Usp (Cpd) Single And Multiple Blood-Pack® Units

  • Rx onlyIntegral Donor Tube (IDT)Use aseptic technique.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.Release pressure on the donor’s arm as appropriate and withdraw donor needle.Precaution: Use care to avoid accidental needle sticks when filling sample tubes. The Fenwal Needle/Tube Sampling Protector may be used to reduce the risk of needle stick injury. 11.Slide sample tube onto needle until stopper is punctured. Release hemostat to fill sample tube. 12.To fill additional tubes, apply a hemostat to donor tube and repeat step 11. 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.Discard needle into an appropriate biohazardous waste container following established procedures. 15.Store suspended CPD Whole Blood/Red Blood Cells between 1 and 6° C. 16.Infuse CPD Whole Blood/Red Blood Cells within 21 days of collection.Dispose of container appropriately. 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, MD.Fenwal, Inc.Lake Zurich, IL 60047 USA1-800-933-6925Made in USAFenwal International, Inc.Road 357, Km. 0.8Maricao, PR 00606– ManufacturerFENWAL and BLOOD-PACK are trademarks of Fenwal, Inc© 2008 Fenwal, Inc. All rights reserved.07-19-58-106 REV: B10/2008

Package/Label Display Panel

  • Code 4R0012MC1 UnitFenwal™Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ UnitSingle For Collection of 450 mL BloodIntegral Donor Tube, 16 ga. Ultra Thin Wall NeedleRx 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, 140 mg Monobasic Sodium Phosphate (monohydrate) USP. pH may have been adjusted with sodium hydroxide.Sterile, non-pyrogenic fluid path.See instructions for use.Store at Controlled Room Temperature (refer to direction insert). •Open pouch by tearing across at notch. •Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth. •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, provided:I)Units are not removed from foil pouch, orII)Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once. •Units removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within 4 days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USA07-28-05-454 REV: A

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