Prescription drug · ANDA
Sodium Citrate 4% w/v Anticoagulant (Trisodium citrate dihydrate) NDC 14537-881
Trisodium citrate dihydrate 4 g/100mL · Injection, Solution · Intravenous · Terumo BCT, Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14537-881-25 | 14537088125 | 30 BAG in 1 CARTON (14537-881-25) / 250 mL in 1 BAGMarketed from Jun 26, 2018 |
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)
- Sodium Citrate 4% w/v Anticoagulant
- Generic name (nonproprietary)
- trisodium citrate dihydrate
- Active ingredients
- Trisodium citrate dihydrate — 4 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Terumo BCT, LtdNDC labeler code 14537
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application BA 125608
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 14537-881_dc65eed1-d14f-4b51-8a84-479852e44ddfSPL ID dc65eed1-d14f-4b51-8a84-479852e44ddfSPL set ID 0775912f-f14a-4967-ac00-c8c1b36040bfUNII B22547B95K
- 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
N414537088125followed by a unit qualifier and the quantityPackage 14537-0881-25. 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)
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2) .] SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 14537-881
- What is NDC 14537-881?
- 14537-881 is the product NDC for Sodium Citrate 4% w/v Anticoagulant, Trisodium citrate dihydrate 4 g/100mL injection, solution, listed with the FDA by Terumo BCT, Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Citrate 4% w/v Anticoagulant (Trisodium citrate dihydrate).
- What is the active ingredient?
- Trisodium citrate dihydrate.
- Who is the labeler?
- Terumo BCT, Ltd, NDC labeler code 14537. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Citrate 4% w/v Anticoagulant?
- 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 BA 125608
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 |
|---|---|---|---|---|
| Sodium Citrate w/v Anticoagulanttrisodium citrate dihydrate | Trisodium citrate dihydrate 4 g/100mL | Injection, SolutionIntravenous | Terumo BCT, Ltd | 14537-883 |