Tranexamic Acid
- Product NDC
- 23155-910
- 11-digit product format
- 231550910
- Labeler code
- 23155
- Product ID
- 23155-910_b131924e-7da3-483a-8511-09f14c985826
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA202436
- Marketing category
- ANDA
- Marketing start
- 2024-11-25
- Substance
- TRANEXAMIC ACID
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tranexamic Acid
- Listing expiration
- 2027-12-31
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 |
|---|
| 23155-910-41 | Tranexamic Acid | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 3 |
| 23155-910-41 | Tranexamic Acid | 10 in 1 CARTON | INJECTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-910 | TRANEXAMIC ACID INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20241126_4f42a81c-37e3-4b57-8e9a-d42c55bbfc52.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-910-41 | 23155091041 | 10 VIAL, SINGLE-DOSE in 1 CARTON (23155-910-41) / 10 mL in 1 VIAL, SINGLE-DOSE | 2024-11-25 | No | No | Historical |