TRANEXAMIC ACID
- Product NDC
- 72485-107
- 11-digit product format
- 724850107
- Labeler code
- 72485
- Product ID
- 72485-107_49a3cee3-011b-4a23-a732-b5ec1c02c590
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRANEXAMIC ACID
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA206713
- Marketing category
- ANDA
- Marketing start
- 2021-06-11
- 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 |
DailyMed Product Concepts#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72485-107-01 | 72485010701 | 1 VIAL, GLASS in 1 CARTON (72485-107-01) / 10 mL in 1 VIAL, GLASS | 2021-06-11 | 0000-00-00 | No | No | Current |
| 72485-107-10 | 72485010710 | 10 VIAL, GLASS in 1 CARTON (72485-107-10) / 10 mL in 1 VIAL, GLASS | 2021-06-11 | 0000-00-00 | No | No | Current |