Tranexamic Acid
- Product NDC
- 67457-197
- 11-digit product format
- 674570197
- Labeler code
- 67457
- Product ID
- 67457-197_a7994e55-1e4d-45bc-bb2c-52b63e4ad408
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA091657
- Marketing category
- ANDA
- Marketing start
- 2011-11-29
- Substance
- TRANEXAMIC ACID
- Active strength
- 100 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 | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6T84R30KC1 |
| Rxcui | 238720 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-197-00 | Tranexamic Acid | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 22 |
| 67457-197-10 | Tranexamic Acid | 10 in 1 PACKAGE | INJECTION, SOLUTION | 10 | | 22 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-197 | TRANEXAMIC ACID INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 20 | Current NDC, Legacy NDC, 2 package rows | 20211120_6f033f1e-8c78-4c87-b870-6493944315ff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-197-00 | 67457019700 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 67457-197-10 | 67457019710 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00) | | 2011-11-29 | 0000-00-00 | No | No | Current |