TRANEXAMIC ACID IN SODIUM CHLORIDE
- Product NDC
- 51754-0108
- 11-digit product format
- 517540108
- Labeler code
- 51754
- Product ID
- 51754-0108_0ae0a575-08e1-43a3-9b6c-8c5f165db35f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Exela Pharma Sciences, LLC
- Application
- NDA212020
- Marketing category
- NDA
- Marketing start
- 2019-06-01
- 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 IN SODIUM CHLORIDE
- 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 |
|---|
| 51754-0108-1 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 1 |
| 51754-0108-3 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 1000 mL in 1 CASE | INJECTION, SOLUTION | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51754-0108 | TRANEXAMIC ACID IN SODIUM CHLORIDE (TRANEXAMIC ACID) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190601_db36ddf2-4ac5-47ac-bdce-e3fa6983073e.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 |
|---|
| 51754-0108-1 | 51754010801 | 100 mL in 1 BAG (51754-0108-1) | 100 ml | 2019-06-01 | 0000-00-00 | No | No | Current |
| 51754-0108-3 | 51754010803 | 1000 mL in 1 CASE (51754-0108-3) | 1000 ml | 2019-06-01 | 0000-00-00 | No | No | Current |