What is NDC 67457-197?

67457-197 is the product NDC for Tranexamic Acid, Tranexamic acid 100 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tranexamic Acid?

43 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tranexamic Acid NDC 67457-197 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-197Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0197Add 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
67457-197-10	6745701971067457019710	10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00)Marketed from Nov 29, 2011

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: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091657
Marketing start: Nov 29, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Fibrinolysis (Physiologic effect)
Identifiers: Product ID 67457-197_a7994e55-1e4d-45bc-bb2c-52b63e4ad408SPL ID a7994e55-1e4d-45bc-bb2c-52b63e4ad408SPL set ID 6f033f1e-8c78-4c87-b870-6493944315ffRxCUI 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

N467457019710 followed by a unit qualifier and the quantity

Package 67457-0197-10. 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 Sep 8, 2025. This label includes a boxed warning.

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)

About NDC 67457-197

What is NDC 67457-197?: 67457-197 is the product NDC for Tranexamic Acid, Tranexamic acid 100 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tranexamic Acid.
What is the active ingredient?: Tranexamic acid.
Who is the labeler?: Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tranexamic Acid?: 43 other product NDCs are listed under this name. See all Tranexamic Acid 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 Tranexamic Acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	NorthStar Rx LLC	72603-818	72603-0818-01
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-028	72319-0028-01
Tranexamic Acid	Tranexamic acid 650 mg/1	TabletOral	Dr. Reddy's Laboratories Inc.	75907-309	75907-0309-30
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Caplin Steriles Limited	65145-106	65145-0106-10
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-909	23155-0909-41
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-910	23155-0910-41
Tranexamic Acid	Tranexamic acid 100 mg/mL	InjectionIntravenous	Northstar Rx LLC	72603-387	72603-0387-10
Tranexamic Acid	Tranexamic acid 1 g/10mL	Injection, SolutionIntravenous	Emcure Pharmaceuticals Limited	14593-318	14593-0318-01
Tranexamic Acid	Tranexamic acid 10 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-418	25021-0418-82
Tranexamic Acid	Tranexamic acid 10 mg/mL	Injection, SolutionIntravenous	Nexus Pharmaceuticals LLC	14789-115	14789-0115-05

All 44 Tranexamic Acid NDCs