Tranexamic Acid
- Product NDC
- 25021-418
- 11-digit product format
- 250210418
- Labeler code
- 25021
- Product ID
- 25021-418_c81489bf-115d-4b9c-a24d-596d0cd53c84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA218599
- Marketing category
- ANDA
- Marketing start
- 2024-09-15
- 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 |
|---|
| 25021-418-82 | Tranexamic Acid | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 1 |
| 25021-418-82 | Tranexamic Acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-418 | TRANEXAMIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20240915_80465b90-3f92-4e35-b2ba-69871bbd4a7f.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 |
|---|
| 25021-418-82 | 25021041882 | 10 BAG in 1 CARTON (25021-418-82) / 100 mL in 1 BAG | 10 bag | 2024-09-15 | No | No | Historical |