NDC codes

FDA NDC Directory
Product NDC (as listed)53877-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53877-0101Add 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
53877-101-0653877010106538770101066 BLISTER PACK in 1 CASE (53877-101-06) / 4 BAG in 1 BLISTER PACK (53877-101-01) / 1 KIT in 1 BAG (53877-101-02) * 63 mL in 1 BAG (53877-111-63) * 100 mL in 1 BAG (53877-121-10)Marketed from May 5, 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)
dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, sodium chloride, mannitol, and adenine
Dosage form
Kit
Route
Intravenous
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 53877-101_ca19d052-4e15-47ae-93b6-10cd8d56861cSPL ID ca19d052-4e15-47ae-93b6-10cd8d56861cSPL set ID 24057196-619a-4218-8e30-35388daee92f

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N453877010106 followed by a unit qualifier and the quantity

Package 53877-0101-06. 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 450 mL ±10% or 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. 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 53877-101

What is NDC 53877-101?
53877-101 is the product NDC for TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL 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?
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).
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 TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL 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
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 Bloodanticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative—KitTerumo Corporation53877-105
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

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