53877-105 NDC - IMUFLEX WB-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (SAVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE FOR COLLECTION OF 500ML OF BLOOD (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE)

Drug Information

Product NDC: 53877-105
Proprietary Name: IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood
Non Proprietary Name: Anticoagulant Citrate Phosphate Dextrose (CPD) and AS-5 Red Cell Preservative
Active Ingredient(s):
Administration Route(s):
Dosage Form(s): KIT

Labeler Information

Field Name	Field Value
Labeler Name:	Terumo Corporation
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	BN880217
Marketing Category:	NDA
Start Marketing Date:	12/15/2010

Package Information

No.	Package Code	Package Description	Billing Unit
1	53877-105-06	15 BLISTER PACK in 1 CASE (53877-105-06) / 1 BAG in 1 BLISTER PACK (53877-105-01) / 1 KIT in 1 BAG (53877-105-02) * 70 mL in 1 BAG (53877-111-70) * 111 mL in 1 BAG (53877-121-11)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	53877-105	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	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.
PROPRIETARY NAME	IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood	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) and AS-5 Red Cell Preservative	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	KIT	The translation of the dosage form Code submitted by the firm.
START MARKETING DATE	12/15/2010	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	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.
APPLICATION NUMBER	BN880217	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.
LABELER NAME	Terumo Corporation	Name of Company corresponding to the labeler code segment of the Product NDC.

Drug Information

Labeler Information

Package Information

NDC Record

Download Record