Tranexamic Acid
- Product NDC
- 14789-115
- 11-digit product format
- 147890115
- Labeler code
- 14789
- Product ID
- 14789-115_2f0e80ab-c6c5-cb03-e063-6394a90a1f92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Nexus Pharmaceuticals LLC
- Application
- ANDA216877
- Marketing category
- ANDA
- Marketing start
- 2024-06-25
- Substance
- TRANEXAMIC ACID
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6T84R30KC1 |
| Rxcui | 2170286 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 14789-115-05 | Tranexamic Acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
| 14789-115-08 | Tranexamic Acid | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14789-115 | TRANEXAMIC ACID INJECTION, SOLUTION [NEXUS PHARMACEUTICALS LLC] | 5 | Current NDC, 2 package rows | 20250302_c479dccd-15c6-47c2-9675-680ebb9db2cb.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 |
|---|
| 14789-115-05 | 14789011505 | 10 BAG in 1 CARTON (14789-115-05) / 100 mL in 1 BAG (14789-115-08) | 10 bag | 2024-06-25 | No | No | Current |
| 14789-115-08 | 14789011508 | 100 mL in 1 BAG | 100 ml | | | | Historical |