Prescription drug · NDA
Additive Formula 3 NDC 14537-833
Dextrose monohydrate 1.1 g/100mL + 5 more ingredients · Solution · Intravenous · Terumo BCT, Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14537-833-03 | 14537083303 | 30 BAG in 1 CASE (14537-833-03) / 200 mL in 1 BAG (14537-833-00)Marketed from May 29, 2002 |
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)
- Additive Formula 3
- Generic name (nonproprietary)
- dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate, and adenine
- Active ingredients
- Dextrose monohydrate — 1.1 g/100mLTrisodium citrate dihydrate — .59 g/100mLSodium chloride — .41 g/100mLSodium phosphate, Monobasic, Monohydrate — .28 g/100mLCitric acid monohydrate — .042 g/100mLAdenine — .03 g/100mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- Terumo BCT, Ltd
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication BN 001214
- 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 14537-833_a93abdba-f409-4b1b-b0d7-ece2189573d9SPL ID a93abdba-f409-4b1b-b0d7-ece2189573d9SPL set ID 9a5247a1-cc05-442d-b2d0-950f887f03c2UNII LX22YL083G, JAC85A2161, 593YOG76RN, 2968PHW8QP, B22547B95K, 451W47IQ8X
- 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
N414537083303followed by a unit qualifier and the quantityPackage 14537-0833-03. 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)
Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2) .] Use only with Trima Accel red blood cell (RBC) apheresis collections. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under BN 001214
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 |
|---|---|---|---|---|
| Additive Formula 3dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate, and adenine | Dextrose monohydrate 1.1 g/100mL + 5 more ingredients | SolutionIntravenous | Terumo BCT, Ltd | 14537-832 |