Prescription drug · ANDA
Tranexamic Acid NDC 72603-818
Tranexamic acid 650 mg/1 · Tablet · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-818-01 | 72603081801 | 30 TABLET in 1 BOTTLE (72603-818-01)Marketed from Aug 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
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205133
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 72603-818_4877eacd-fda7-4708-93a5-81052c1d2e14SPL ID 4877eacd-fda7-4708-93a5-81052c1d2e14SPL set ID 4877eacd-fda7-4708-93a5-81052c1d2e14RxCUI 883826UNII 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
N472603081801followed by a unit qualifier and the quantityPackage 72603-0818-01. 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.
Other NDCs under ANDA 205133
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 | Aurobindo Pharma Limited | 59651-839 |