NDC 62646-798 Anticoagulant Sodium Citrate

NDC Product Code 62646-798

NDC 62646-798-60

Package Description: 250 mL in 1 BAG

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Anticoagulant Sodium Citrate with NDC 62646-798 is a product labeled by Medsep Corporation. The generic name of Anticoagulant Sodium Citrate is . The product's dosage form is and is administered via form.

Labeler Name: Medsep Corporation

Dosage Form: -

Product Type: 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.

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.

  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Medsep Corporation
Labeler Code: 62646
Start Marketing Date: 04-15-2011 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: 12-31-2017 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: I 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.

Anticoagulant Sodium Citrate Product Label Images

Anticoagulant Sodium Citrate 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 Sodium Citrate Solution, Usp

Sterile, non-pyrogenic fluid path. Sterilized by steam.Rx only.250 ml volume bag. Store at room temperature.

Indications And Usage

For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.

Warnings

Not for direct intravenous infusion.DO NOT VENT.Avoid excessive heat. Protect from freezing.

General Precautions

Do not use unless solution is clear and no leaks are detected.Discard unused portion.

How Supplied

Single Use Container.

Information For Patients

Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USAVisit us at www.pall.com/medicalFor Pall customer service, call: 1.800.645.6578

Container Text Displayed

Anticoagulant Sodium Citrate Bag TextANTICOAGULANT SODIUM CITRATE SOLUTION, USP250 mL Code 798-60For use with automated plasmapheresis equipment only. Each 250 mL of anticoagulant contains 10.0 g sodium citrate (dihydrate), USP (pH adjusted with citric acid, USP).CAUTION: Not for direct intravenous infusion.Do not use unless anticoagulant is clear. This unit should be used for plasmapheresis only. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.DO NOT VENT.

* Please review the disclaimer below.