tranexamic acid
- Product NDC
- 83634-401
- 11-digit product format
- 836340401
- Labeler code
- 83634
- Product ID
- 83634-401_5dece4b5-d95e-4fe7-b0ed-89bd573f2fad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avenacy, Inc.
- Application
- ANDA203521
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- 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 |
|---|
| 83634-401-10 | tranexamic acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 83634-401-41 | tranexamic acid | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-401 | TRANEXAMIC ACID INJECTION, SOLUTION [AVENACY, INC.] | 1 | Current NDC, 2 package rows | 20240601_00630e54-0e84-465d-96a5-63486c87dcd9.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 |
|---|
| 83634-401-10 | 83634040110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41) | | 2024-06-01 | No | No | Current |
| 83634-401-41 | 83634040141 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |