What is NDC 71357-001?

71357-001 is the product NDC for Tromethamine, Tromethamine 3.6 g/100mL injection, solution, listed with the FDA by MILLA PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

MILLA PHARMACEUTICALS INC., NDC labeler code 71357. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tromethamine NDC 71357-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71357-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71357-0001Add 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 NDC	11-digit (billing)	Package	Copy
71357-001-01	7135700010171357000101	6 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06)Marketed from Dec 31, 2024

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): Tromethamine
Generic name (nonproprietary): tromethamine
Active ingredients: Tromethamine — 3.6 g/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: MILLA PHARMACEUTICALS INC.NDC labeler code 71357
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213116
Marketing start: Dec 31, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 71357-001_47d8e7ea-786a-263c-e063-6394a90a6a18SPL ID 47d8e7ea-786a-263c-e063-6394a90a6a18SPL set ID 082b1104-502b-47af-95bf-0dbf2422990eRxCUI 198412UNII 023C2WHX2VUPC 0371357001065

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

N471357000101 followed by a unit qualifier and the quantity

Package 71357-0001-01. 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 Jan 7, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 71357-001

What is NDC 71357-001?: 71357-001 is the product NDC for Tromethamine, Tromethamine 3.6 g/100mL injection, solution, listed with the FDA by MILLA PHARMACEUTICALS 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?: MILLA PHARMACEUTICALS INC., NDC labeler code 71357. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tromethamine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tromethamine	Tromethamine 3.6 g/100mL	Injection, SolutionIntravenous	B. Braun Medical Inc.	0264-8031	00264-8031-10