TRANEXAMIC ACID
- Product NDC
- 43066-008
- 11-digit product format
- 430660008
- Labeler code
- 43066
- Product ID
- 43066-008_aa76c2c6-9374-44d5-a037-4e2b6ffea859
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA212360
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- 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 |
|---|
| 43066-008-01 | TRANEXAMIC ACID | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 8 |
| 43066-008-10 | TRANEXAMIC ACID | 1 in 1 CARTON | INJECTION | 1 | | 8 |
| 43066-008-10 | TRANEXAMIC ACID | 10 in 1 BOX | INJECTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43066-008 | TRANEXAMIC ACID INJECTION [BAXTER HEALTHCARE CORPORATION] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240922_32750a05-6617-46e8-b9e7-04e613e6bf4b.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 |
|---|
| 43066-008-01 | 43066000801 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 43066-008-10 | 43066000810 | 10 CARTON in 1 BOX (43066-008-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (43066-008-01) | 10 carton | 2020-07-01 | 0000-00-00 | No | No | Current |