NDC codes

FDA NDC Directory
Product NDC (as listed)53877-105Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53877-0105Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53877-105-065387701050615 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)Marketed from Dec 15, 2010

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Generic name (nonproprietary)
anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative
Dosage form
Kit
Labeler
Terumo CorporationNDC labeler code 53877
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication BN 880217
Marketing start
Listing expires
Identifiers
Product ID 53877-105_d1e10bfe-e386-4d21-9235-15ef3953e08fSPL ID d1e10bfe-e386-4d21-9235-15ef3953e08fSPL set ID ebaeef7d-abb9-4327-bb34-18d146a07376

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N453877010506 followed by a unit qualifier and the quantity

Package 53877-0105-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

1. INDICATIONS AND USAGE 1.1. Read these instructions carefully before use. 1.2. Rx ONLY. 1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4. For the collection of 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 1.6. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature. 1.7. For further processing, use standard component processing techniques.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53877-105

What is NDC 53877-105?
53877-105 is the product NDC for 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 kit, listed with the FDA by Terumo Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this 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).
Who is the labeler?
Terumo Corporation, NDC labeler code 53877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for 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?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under BN 880217

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BN 880217
ProductStrengthForm · routeLabelerProduct NDC
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 Preservativeanticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative—KitIntravenousTerumo Corporation53877-006
Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of Bloodanticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative—KitTerumo BCT Vietnam CO., Ltd.82906-506
TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blooddextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, anhydrous dextrose, sodium chloride, mannitol, and adenine—KitTerumo Corporation53877-103
TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of Blooddextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, sodium chloride, mannitol, and adenine—KitIntravenousTerumo Corporation53877-101

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