TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL Red Cell Preservative

Product NDC: 53877-005
Requested package NDC: 53877-005-21
11-digit product format: 538770005
Labeler code: 53877
Product ID: 53877-005_4a524a51-df6c-4cc7-8695-72e302a92474
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative
Dosage form: KIT
Route: INTRAVENOUS
Labeler: Terumo Corporation
Application: BN880217
Marketing category: NDA
Marketing start: 2010-01-13
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53877-005	53877-005-21	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53877-005-21	2025-02-11	C162847	48780-1	2cef2736-6b7b-d83d-e063-dadaa90ab31f	TERUFLEX® BLOOD BAG SYSTEM CPD/OPTISOL® SOLUTION BLOOD BAG SYSTEM
53877-005-21	2025-01-30	C162847	48780-1	2cef2736-6b7b-d83d-e063-dadaa90ab31f	TERUFLEX® BLOOD BAG SYSTEM CPD/OPTISOL® SOLUTION BLOOD BAG SYSTEM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Adenine	ACTIVE INGREDIENT	JAC85A2161	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Adenine	ACTIVE INGREDIENT	JAC85A2161	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Anhydrous Citric Acid	ACTIVE INGREDIENT	XF417D3PSL	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Anhydrous Citric Acid	ACTIVE INGREDIENT	XF417D3PSL	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Dextrose Monohydrate	ACTIVE INGREDIENT	LX22YL083G	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Dextrose Monohydrate	ACTIVE INGREDIENT	LX22YL083G	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Mannitol	ACTIVE INGREDIENT	3OWL53L36A	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Mannitol	ACTIVE INGREDIENT	3OWL53L36A	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Sodium Chloride	ACTIVE INGREDIENT	451W47IQ8X	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Sodium Chloride	ACTIVE INGREDIENT	451W47IQ8X	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Sodium Phosphate, Monobasic	ACTIVE INGREDIENT	3980JIH2SW	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Sodium Phosphate, Monobasic	ACTIVE INGREDIENT	3980JIH2SW	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Trisodium Citrate Dihydrate	ACTIVE INGREDIENT	B22547B95K	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Trisodium Citrate Dihydrate	ACTIVE INGREDIENT	B22547B95K	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Adenine	ACTIVE MOIETY	JAC85A2161	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Adenine	ACTIVE MOIETY	JAC85A2161	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Citric Acid	ACTIVE MOIETY	2968PHW8QP	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Citric Acid	ACTIVE MOIETY	2968PHW8QP	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Dextrose	ACTIVE MOIETY	IY9XDZ35W2	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Dextrose	ACTIVE MOIETY	IY9XDZ35W2	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Mannitol	ACTIVE MOIETY	3OWL53L36A	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Mannitol	ACTIVE MOIETY	3OWL53L36A	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Phosphoric Acid	ACTIVE MOIETY	E4GA8884NN	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Phosphoric Acid	ACTIVE MOIETY	E4GA8884NN	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of Blood	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE	Terumo BCT Vietnam CO., Ltd.	58bdabc8-283a-47bd-8abe-dd9284f3f497	2025-01-14	Warnings, Adverse reactions	Exact identifier application number: BN880217
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	Terumo Corporation	ebaeef7d-abb9-4327-bb34-18d146a07376	2024-12-17	Warnings	Exact identifier application number: BN880217
TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blood	DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, ANHYDROUS CITRIC ACID, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, SODIUM CHLORIDE, MANNITOL, AND ADENINE	Terumo Corporation	24057196-619a-4218-8e30-35388daee92f	2024-10-10	Warnings	Exact identifier application number: BN880217
TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood	DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, ANHYDROUS CITRIC ACID, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, ANHYDROUS DEXTROSE, SODIUM CHLORIDE, MANNITOL, AND ADENINE	Terumo Corporation	5b8b3dbb-b57b-4706-a7aa-daa173caffa2	2024-10-07	Warnings	Exact identifier application number: BN880217
IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE	Terumo Corporation	8b22a4c8-2d6e-45d5-82e2-02ef0b713095	2024-08-27	Warnings	Exact identifier application number: BN880217

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53877-005-21	53877000521	24 BAG in 1 CASE (53877-005-21) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG	24 bag	2010-01-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TERUFLEX® BLOOD BAG SYSTEM CPD/OPTISOL® SOLUTION BLOOD BAG SYSTEM	Terumo Corporation \| Terumo Corp. - Fujinomiya Factory	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	5
TERUFLEX® BLOOD BAG SYSTEM CPD/OPTISOL® SOLUTION BLOOD BAG SYSTEM	Terumo Corporation \| Terumo Corp. - Fujinomiya Factory	2019-12-11	HUMAN PRESCRIPTION DRUG LABEL	5