Prescription drug · ANDA
Tranexamic Acid NDC 25021-415
Tranexamic acid 100 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-415-10 | 2502104151025021041510 | 10 VIAL in 1 CARTON (25021-415-10) / 10 mL in 1 VIALMarketed from Jul 15, 2023 |
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
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207239
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 25021-415_3fd920b8-1b08-4882-9ed4-dd1b5b52af94SPL ID 3fd920b8-1b08-4882-9ed4-dd1b5b52af94SPL set ID 0277db2d-7c81-4cd0-ac19-fa12b5721428RxCUI 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
N425021041510followed by a unit qualifier and the quantityPackage 25021-0415-10. 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 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 25021-415
- What is NDC 25021-415?
- 25021-415 is the product NDC for Tranexamic Acid, Tranexamic acid 100 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. 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?
- Sagent Pharmaceuticals, NDC labeler code 25021. 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 207239
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 | HF Acquisition Co LLC, DBA HealthFirst | 51662-1714 |
| Tranexamic acid | Tranexamic acid 100 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-160 |