Prescription drug · ANDA
Tromethamine NDC 0264-8031
Tromethamine 3.6 g/100mL · Injection, Solution · Intravenous · B. Braun Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0264-8031-10 | 0026480311000264803110 | 24 BAG in 1 CASE (0264-8031-10) / 500 mL in 1 BAGMarketed from Aug 27, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tromethamine
- Generic name (nonproprietary)
- tromethamine
- Active ingredients
- Tromethamine — 3.6 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- B. Braun Medical Inc.NDC labeler code 0264
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211558
- Marketing start
- Listing expires
- Identifiers
- Product ID 0264-8031_87d30389-4483-4d62-a623-d4676e7d16c9SPL ID 87d30389-4483-4d62-a623-d4676e7d16c9SPL set ID 57db5686-7f7f-4999-87e3-e1cbbda4a98dRxCUI 198412UNII 023C2WHX2V
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
N400264803110followed by a unit qualifier and the quantityPackage 00264-8031-10. 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)
INDICATIONS AND USAGE Tromethamine Injection is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery. Tromethamine Injection has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery. It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity. Tromethamine Injection may be…
Excerpt only. Read the full label for complete information.
About NDC 0264-8031
- What is NDC 0264-8031?
- 0264-8031 is the product NDC for Tromethamine, Tromethamine 3.6 g/100mL injection, solution, listed with the FDA by B. Braun Medical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tromethamine.
- What is the active ingredient?
- Tromethamine.
- Who is the labeler?
- B. Braun Medical Inc., NDC labeler code 0264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tromethamine?
- 1 other product NDC are listed under this name. See all Tromethamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tromethamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tromethamine | Tromethamine 3.6 g/100mL | Injection, SolutionIntravenous | MILLA PHARMACEUTICALS INC. | 71357-001 | 71357-0001-01 |