TRANEXAMIC ACID
- Product NDC
- 82804-208
- 11-digit product format
- 828040208
- Labeler code
- 82804
- Product ID
- 82804-208_416cdb61-31fb-4554-835f-a7744aa33b61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRANEXAMIC ACID
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA218320
- Marketing category
- ANDA
- Marketing start
- 2024-06-11
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRANEXAMIC ACID
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRANEXAMIC ACID | 650 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6T84R30KC1 |
| Rxcui | 883826 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-208-15 | TRANEXAMIC ACID | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-208 | TRANEXAMIC ACID TABLET [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20250321_416cdb61-31fb-4554-835f-a7744aa33b61.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-208-15 | 82804020815 | 15 TABLET in 1 BOTTLE (82804-208-15) | 15 tablet | 2024-06-11 | No | No | Current |