Prescription drug · ANDA
Tranexamic Acid In Sodium Chloride (Tranexamic acid) NDC 68083-613
Tranexamic acid 10 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-613-10 | 6808306131068083061310 | 10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Apr 16, 2024 |
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 In Sodium Chloride
- Generic name (nonproprietary)
- tranexamic acid
- Active ingredients
- Tranexamic acid — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218599
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 68083-613_71e0764f-b584-49fb-ba62-11f3fb32d3fcSPL ID 71e0764f-b584-49fb-ba62-11f3fb32d3fcSPL set ID f06f07de-bedf-4b37-b15e-0959e0a154e6RxCUI 2170286UNII 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
N468083061310followed by a unit qualifier and the quantityPackage 68083-0613-10. 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 in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic Acid in Sodium Chloride Injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (two to eight 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 68083-613
- What is NDC 68083-613?
- 68083-613 is the product NDC for Tranexamic Acid In Sodium Chloride, Tranexamic acid 10 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tranexamic Acid In Sodium Chloride (Tranexamic acid).
- What is the active ingredient?
- Tranexamic acid.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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 In Sodium Chloride?
- 5 other product NDCs are listed under this name. See all Tranexamic Acid In Sodium Chloride 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 In Sodium Chloride 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 in sodium chloridetranexamic acid | Tranexamic acid 10 mg/mL | Injection, SolutionIntravenous | Avenacy Inc. | 83634-403 | 83634-0403-51 |
| Tranexamic Acid in Sodium Chloridetranexamic acid | Tranexamic acid 10 mg/mL | Injection, SolutionIntravenous | HP Halden Pharma AS | 66298-5340 | 66298-5340-01 |
| Tranexamic Acid In Sodium Chloridetranexamic acid | Tranexamic acid 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-534 | 65219-0534-10 |
| Tranexamic Acid In Sodium Chloridetranexamic acid | Tranexamic acid 10 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2329 | 80830-2329-0280830-2329-03 |
| Tranexamic Acid In Sodium Chloridetranexamic acid | Tranexamic acid 10 mg/mL | Injection, SolutionIntravenous | Exela Pharma Sciences, LLC | 51754-0108 | 51754-0108-0151754-0108-03 |
Other NDCs under ANDA 218599
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 10 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-418 |