Tranexamic Acid
- Product NDC
- 55150-188
- 11-digit product format
- 551500188
- Labeler code
- 55150
- Product ID
- 55150-188_e8b14a77-9700-431c-a699-8a0984cc5c21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA205035
- Marketing category
- ANDA
- Marketing start
- 2016-01-14
- 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 |
|---|
| 55150-188-10 | Tranexamic Acid | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 9 |
| 55150-188-10 | Tranexamic Acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-188 | TRANEXAMIC ACID INJECTION, SOLUTION [EUGIA US LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240220_246a3c6c-a7fb-45c7-9509-49a48a5bdcc6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-188-10 | 55150018810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-188-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2016-01-14 | 0000-00-00 | No | No | Current |