Tranexamic Acid
- Product NDC
- 63629-8838
- 11-digit product format
- 636298838
- Labeler code
- 63629
- Product ID
- 63629-8838_30e26790-6561-4a6a-938c-67ce81739ba2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202093
- Marketing category
- ANDA
- Marketing start
- 2013-01-03
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-8838-1 | 63629883801 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-8838-1) | 2021-09-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tranexamic Acid | Bryant Ranch Prepack | 2024-01-15 | HUMAN PRESCRIPTION DRUG LABEL | 103 |