tranexamic acid NDC 81284-612

NDC codes

FDA NDC Directory

Product NDC (as listed)81284-612Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81284-0612Add 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
81284-612-10	81284061210	10 VIAL, SINGLE-DOSE in 1 CARTON (81284-612-10) / 10 mL in 1 VIAL, SINGLE-DOSE (81284-612-00)Marketed from Sep 30, 2021

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): tranexamic acid
Generic name (nonproprietary): tranexamic acid
Active ingredients: Tranexamic acid — 100 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Provepharm Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212676
Marketing start: Sep 30, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Fibrinolysis (Physiologic effect)
Identifiers: Product ID 81284-612_9319bf8d-71d6-40da-8ea6-39036da7d192SPL ID 9319bf8d-71d6-40da-8ea6-39036da7d192SPL set ID 1b8c3500-8e87-4b6e-b6a9-8da5f9c00820RxCUI 238720UNII 6T84R30KC1
Pharmacologic class: Antifibrinolytic 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.

How CPT relates to drug billing

NDC on a medical claim

N481284061210 followed by a unit qualifier and the quantity

Package 81284-0612-10. 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 Aug 12, 2025.

Indications (excerpt from the label)

Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212676

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212676
Product	Strength	Form · route	Labeler	Product NDC
Tranexamic Acid	Tranexamic acid 100 mg/mL	Injection, SolutionIntravenous	Milla Pharmaceuticals Inc.	71357-017
Tranexamic Acid	Tranexamic acid 100 mg/mL	Injection, SolutionIntravenous	Milla Pharmaceuticals Inc.	71357-018
tranexamic acid	Tranexamic acid 100 mg/mL	Injection, SolutionIntravenous	Provepharm Inc.	81284-611