Prescription drug · ANDA
Tranexamic Acid NDC 72578-220
Tranexamic acid 650 mg/1 · Tablet · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-220-06 | 7257802200672578022006 | 30 TABLET in 1 BOTTLE (72578-220-06)Marketed from Nov 1, 2026 |
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 — 650 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viona Pharmaceuticals IncNDC labeler code 72578
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 221213
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 72578-220_b8613d4e-453f-4f45-82c8-50803881383bSPL ID b8613d4e-453f-4f45-82c8-50803881383bSPL set ID 40e3e10f-a787-42f2-a2c0-0ce2cb1ab916UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472578022006followed by a unit qualifier and the quantityPackage 72578-0220-06. 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 tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies ( 14 )]. Tranexamic acid tablets are an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 72578-220
- What is NDC 72578-220?
- 72578-220 is the product NDC for Tranexamic Acid, Tranexamic acid 650 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals 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?
- Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 221213
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 650 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1989 |