Tranexamic Acid
- Product NDC
- 42571-189
- 11-digit product format
- 425710189
- Labeler code
- 42571
- Product ID
- 42571-189_45fc1537-9ab6-d1e9-e063-6394a90ab620
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Micro Labs Limited
- Application
- ANDA206713
- Marketing category
- ANDA
- Marketing start
- 2017-08-01
- 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 |
|---|
| 42571-189-56 | Tranexamic Acid | 10 mL in 1 AMPULE | INJECTION | 10 | | 13 |
| 42571-189-56 | Tranexamic Acid | 1 in 1 CARTON | INJECTION | 1 | | 13 |
| 42571-189-57 | Tranexamic Acid | 10 in 1 CARTON | INJECTION | 10 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-189 | TRANEXAMIC ACID (TRANEXAMIC ACID) INJECTION TRANEXAMIC ACID (TRANEXAMIC ACID) INJECTION [MICRO LABS LIMITED] | 11 | Current NDC, Legacy NDC, 3 package rows | 20210615_ee5aeb09-40fb-40f9-b655-97c50652a05e.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 |
|---|
| 42571-189-56 | 42571018956 | 10 mL in 1 AMPULE | 10 ml | | | | | Historical |
| 42571-189-57 | 42571018957 | 10 CARTON in 1 CARTON (42571-189-57) / 1 AMPULE in 1 CARTON (42571-189-56) / 10 mL in 1 AMPULE | 10 carton | 2017-08-01 | 0000-00-00 | No | No | Current |