Prescription drug · NDA AUTHORIZED GENERIC
Tranexamic Acid NDC 50268-772
Tranexamic acid 650 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-772-13 | 5026807721350268077213 | 30 BLISTER PACK in 1 BOX (50268-772-13) / 1 TABLET in 1 BLISTER PACK (50268-772-11)Marketed from Sep 16, 2022 |
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
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022430
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 50268-772_48364f64-73b3-8c92-e063-6294a90a8b46SPL ID 48364f64-73b3-8c92-e063-6294a90a8b46SPL set ID e8cdb0d6-9498-2902-e053-2995a90a9de4RxCUI 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
N450268077213followed by a unit qualifier and the quantityPackage 50268-0772-13. 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 USP tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies (14) ]. Tranexamic acid USP tablets is 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 50268-772
- What is NDC 50268-772?
- 50268-772 is the product NDC for Tranexamic Acid, Tranexamic acid 650 mg/1 tablet, listed with the FDA by AvPAK. 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?
- AvPAK, NDC labeler code 50268. 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 NDA 022430
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 | Nordic Pharma, Inc. | 69918-301 |