Prescription drug · ANDA
Tranexamic Acid NDC 71357-017
Tranexamic acid 100 mg/mL · Injection, Solution · Intravenous · Milla Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct 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
- Milla Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212676
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 71357-017_5a3881b8-ac8b-a1c5-e063-6294a90a6041SPL ID 5a3881b8-ac8b-a1c5-e063-6294a90a6041SPL set ID fb2fcae9-6aa0-4708-b250-b0e40beb147eRxCUI 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
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 injection 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.
Other NDCs under ANDA 212676
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 | Milla Pharmaceuticals Inc. | 71357-018 |
| tranexamic acid | Tranexamic acid 100 mg/mL | Injection, SolutionIntravenous | Provepharm Inc. | 81284-612 |
| tranexamic acid | Tranexamic acid 100 mg/mL | Injection, SolutionIntravenous | Provepharm Inc. | 81284-611 |