Tranexamic Acid
- Product NDC
- 72485-510
- 11-digit product format
- 724850510
- Labeler code
- 72485
- Product ID
- 72485-510_a3468b9f-a1c1-43ca-afc0-5b32c8f58b83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA212360
- Marketing category
- ANDA
- Marketing start
- 2024-02-06
- 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 |
|---|
| 72485-510-01 | Tranexamic Acid | 10 mL in 1 VIAL | INJECTION | 10 | | 1 |
| 72485-510-10 | Tranexamic Acid | 10 in 1 CARTON | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-510 | TRANEXAMIC ACID INJECTION [ARMAS PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20240214_a3468b9f-a1c1-43ca-afc0-5b32c8f58b83.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72485-510-01 | 72485051001 | 10 mL in 1 VIAL | 10 ml | | | | Historical |
| 72485-510-10 | 72485051010 | 10 VIAL in 1 CARTON (72485-510-10) / 10 mL in 1 VIAL (72485-510-01) | 10 vial | 2024-02-06 | No | No | Current |