tranexamic acid in sodium chloride
- Product NDC
- 83634-403
- 11-digit product format
- 836340403
- Labeler code
- 83634
- Product ID
- 83634-403_3de7c58b-1244-4ba9-af17-7a7f318e1255
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avenacy Inc.
- Application
- ANDA218896
- Marketing category
- ANDA
- Marketing start
- 2025-09-01
- Substance
- TRANEXAMIC ACID
- Active strength
- 10 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 in sodium chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRANEXAMIC ACID | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6T84R30KC1 |
| Rxcui | 2170286 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83634-403-51 | tranexamic acid in sodium chloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
| 83634-403-82 | tranexamic acid in sodium chloride | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-403-51 | 83634040351 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-403-51) / 100 mL in 1 VIAL, SINGLE-DOSE (83634-403-82) | | 2025-09-01 | No | No | Current |
| 83634-403-82 | 83634040382 | 100 mL in 1 VIAL, SINGLE-DOSE | 100 ml | | | | Historical |