Tranexamic Acid
- Product NDC
- 60505-6169
- 11-digit product format
- 605056169
- Labeler code
- 60505
- Product ID
- 60505-6169_9002dad4-1b99-59ce-1c71-810a1821f0d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Apotex Corp.
- Application
- ANDA209860
- Marketing category
- ANDA
- Marketing start
- 2020-08-05
- Substance
- TRANEXAMIC ACID
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6T84R30KC1 | TRANEXAMIC ACID | 1197-18-8 | TRANEXAMIC ACID |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-6169-1 | 60505616901 | 10 VIAL in 1 CARTON (60505-6169-1) / 10 mL in 1 VIAL | 10 vial | 2020-08-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tranexamic Acid | Apotex Corp. | Apotex Inc. | 2025-09-22 | HUMAN PRESCRIPTION DRUG LABEL | 11 |