TRANEXAMIC ACID
- Product NDC
- 59651-839
- 11-digit product format
- 596510839
- Labeler code
- 59651
- Product ID
- 59651-839_773eb919-7d48-4ba2-af58-aa169f0ea75f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRANEXAMIC ACID
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA205133
- Marketing category
- ANDA
- Marketing start
- 2023-12-04
- Substance
- TRANEXAMIC ACID
- Active strength
- 650 mg/1
- 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 |
|---|
| 59651-839-30 | 59651083930 | 30 TABLET in 1 BOTTLE (59651-839-30) | 30 tablet | 2023-12-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TRANEXAMIC ACID | Aurobindo Pharma Limited | 2023-12-07 | Human Prescription Drug Label | 1 |