Tranexamic Acid
- Product NDC
- 14593-318
- 11-digit product format
- 145930318
- Labeler code
- 14593
- Product ID
- 14593-318_996040a7-8eaa-4dcc-ba36-5c37d4db8113
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Emcure Pharmaceuticals Limited
- Application
- ANDA203521
- Marketing category
- ANDA
- Marketing start
- 2024-10-28
- Substance
- TRANEXAMIC ACID
- Active strength
- 1 g/10mL
- 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 | 1 g/10mL |
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 |
|---|
| 14593-318-01 | Tranexamic Acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 14593-318-01 | Tranexamic Acid | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14593-318 | TRANEXAMIC ACID INJECTION, SOLUTION [EMCURE PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20241030_ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a.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 |
|---|
| 14593-318-01 | 14593031801 | 10 VIAL in 1 CARTON (14593-318-01) / 10 mL in 1 VIAL | 10 vial | 2024-10-28 | No | No | Current |