NDC 0942-9502 Sodium Citrate Blood-pack Units, (pl 146 Plastic)

Anticoagulant Sodium Citrate Solution

NDC Product Code 0942-9502

NDC Code: 0942-9502

Proprietary Name: Sodium Citrate Blood-pack Units, (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 Sodium Citrate Solution 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.
    • 0942-9502 - Sodium Citrate Blood-pack Units, (pl 146 Plastic)

NDC 0942-9502-06

Package Description: 50 mL in 1 BAG

NDC Product Information

Sodium Citrate Blood-pack Units, (pl 146 Plastic) with NDC 0942-9502 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Sodium Citrate Blood-pack Units, (pl 146 Plastic) is anticoagulant sodium citrate solution. 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.

Sodium Citrate Blood-pack Units, (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 2 g/50mL

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)

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: BN770923 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.

Sodium Citrate Blood-pack Units, (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 And Plasmapheresis Using Double Plasmapheresis Blood-Packtm Unit

  • Rx onlyUse aseptic technique.Precaution: Do not use unless solution is clear.1.Identify Blood-Pack unit using appropriate donor identification system. Confirm that the numbers on the tubing of each Blood-Pack unit container are present and identical.2.Attach one lead of a multiple lead blood-solution recipient set to a container of 0.9% Sodium Chloride Injection, USP following instructions on recipient set carton. 3. Clamp tubing of each Blood-Pack container. 4. Remove plug from end of manifold and immediately insert needle adapter of primed recipient set. 5. Position primary container on the donor scale as far as possible below donor arm. 6. Apply pressure to donor’s arm and disinfect site of venipuncture. 7. If blood pressure cuff is used, inflate to approximately 60 mmHg. 8. Remove needle cover and accomplish venipuncture 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. c. Accomplish venipuncture. 9. Open clamp on tubing of one Blood-Pack container to permit flow of blood. 10. Mix blood and anticoagulant at several intervals during collection and immediately after collection. 11. Collect specified volume of blood. 12. Release pressure as appropriate on the donor’s arm. 13. Make two seals below first number on container tubing, and sever tubing between seals. 14. Flush donor tubing with intravenous solution and adjust flow to slow drip to maintain patency of phlebotomy needle. 15. Centrifuge container to achieve plasma-red cell separation following standard procedures. 16. Transfer plasma to an appropriate container. Seal transfer tubing in two places and sever tubing between seals. 17. Utilize more than one identification system following standard procedures. Before infusing red cells, confirm the identity of the intended recipient as the original donor by comparing remaining segment numbers on severed tubing with segment number on Blood-Pack unit. Do not rely on segment numbers alone. 18. Attach Blood-Pack unit to unused lead of recipient set. Close clamp under intravenous solution container and open clamp on the Blood-Pack unit. Infuse red cells. 19. When red cells have been infused, flush tubing with intravenous solution. 20. Close lower clamp on recipient set. 21. If blood pressure cuff is used, inflate to approximately 60 mmHg. 22. Repeat steps 9-19 for second unit of blood. 23. Clamp tubing; remove needle from donor’s arm; bandage venipuncture site. 24. Discard bags, tubing and needle according to current guidelines for handling biohazardous material.

Package/Label Display Panel

  • Fenwal™Anticoagulant Sodium Citrate Solution, USP, BLOOD-PACK™ UnitDouble For Collection and Processing of Two 500 mL Units of Blood 16 ga. NeedleRx onlyEach unit consists of two PL 146 Plastic containers, each with 50 mL of Anticoagulant Sodium Citrate Solution, USP containing 2 g Sodium Citrate (dihydrate) USP. Not intended for storage or homologous transfusion of red cells.These units should be used for plasmapheresis only.Sterile, non-pyrogenic fluid pathSee 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:l) Units are not removed from foil pouch, orll) 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 USA07-28-05-516 REV: A

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