Tranexamic Acid
- Product NDC
- 0517-0960
- 11-digit product format
- 005170960
- Labeler code
- 0517
- Product ID
- 0517-0960_1a8db732-66d1-443c-9664-08f9e84903f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA201885
- Marketing category
- ANDA
- Marketing start
- 2011-11-15
- 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 |
|---|
| 0517-0960-01 | Tranexamic Acid | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 19 |
| 0517-0960-01 | Tranexamic Acid | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 19 |
| 0517-0960-10 | Tranexamic Acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 19 |
| 0517-0960-10 | Tranexamic Acid | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-0960 | TRANEXAMIC ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 19 | Current NDC, Legacy NDC, 4 package rows | 20210501_81916afc-f83a-4bba-a810-17393980e27e.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 |
|---|
| 0517-0960-01 | 00517096001 | 1 VIAL, GLASS in 1 CARTON (0517-0960-01) / 10 mL in 1 VIAL, GLASS | 2011-11-15 | 0000-00-00 | No | No | Current |
| 0517-0960-10 | 00517096010 | 10 VIAL, GLASS in 1 CARTON (0517-0960-10) / 10 mL in 1 VIAL, GLASS | 2011-11-15 | 0000-00-00 | No | No | Current |