Prescription drug · ANDA
tranexamic acid NDC 81284-612
Tranexamic acid 100 mg/mL · Injection, Solution · Intravenous · Provepharm Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81284-612-10 | 8128406121081284061210 | 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.NDC labeler code 81284
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212676
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N481284061210followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 81284-612
- What is NDC 81284-612?
- 81284-612 is the product NDC for tranexamic acid, Tranexamic acid 100 mg/mL injection, solution, listed with the FDA by Provepharm Inc.. 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?
- Provepharm Inc., NDC labeler code 81284. 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.
Related NDCs: other tranexamic acid products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 212676
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 |
|---|---|---|---|---|
| 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 |