Prescription drug · NDA
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1 NDC 53877-109
Anhydrous citric acid 2.99 g/1000mL + 4 more ingredients · Solution · Intravenous · Terumo Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53877-109-06 | 5387701090653877010906 | 6 BLISTER PACK in 1 CASE (53877-109-06) / 4 BAG in 1 BLISTER PACK (53877-109-01) / 70 mL in 1 BAG (53877-109-02)Marketed from May 22, 2012 |
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
- Brand name (proprietary)
- TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1
- Generic name (nonproprietary)
- anhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, dextrose monohydrate, and adenine
- Active ingredients
- Anhydrous citric acid — 2.99 g/1000mLTrisodium citrate dihydrate — 26.3 g/1000mLSodium phosphate, Monobasic, Monohydrate — 2.22 g/1000mLDextrose monohydrate — 31.9 g/1000mLAdenine — .275 g/1000mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- Terumo CorporationNDC labeler code 53877
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication BN 820528
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 53877-109_36892628-1b13-4330-bd0b-390a30dc67eeSPL ID 36892628-1b13-4330-bd0b-390a30dc67eeSPL set ID 39f2e11c-5a31-469f-b725-d096c1674421UNII XF417D3PSL, B22547B95K, 593YOG76RN, LX22YL083G, JAC85A2161
- Pharmacologic class
- Anti-coagulant; Calculi Dissolution Agent
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.
- NDC on a medical claim
N453877010906followed by a unit qualifier and the quantityPackage 53877-0109-06. 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.
About NDC 53877-109
- What is NDC 53877-109?
- 53877-109 is the product NDC for TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1, Anhydrous citric acid 2.99 g/1000mL + 4 more ingredients solution, 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 70 mL CPDA-1 (Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, and Adenine).
- What is the active ingredient?
- Anhydrous citric acid, Trisodium citrate dihydrate, Sodium phosphate, Monobasic, Monohydrate, Dextrose monohydrate, 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 70 mL CPDA-1?
- 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 820528
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Bloodanhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, dextrose monohydrate, and adenine | Anhydrous citric acid 2.99 g/1000mL + 4 more ingredients | SolutionIntravenous | Terumo Corporation | 53877-108 |
| teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1anhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, dextrose monohydrate, and adenine | Anhydrous citric acid 2.99 g/1000mL + 4 more ingredients | SolutionIntravenous | Terumo Corporation | 53877-110 |