Tranexamic acid
- Product NDC
- 68083-160
- 11-digit product format
- 680830160
- Labeler code
- 68083
- Product ID
- 68083-160_3756c37f-5de9-49d4-a756-89cbd5c237e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA207239
- Marketing category
- ANDA
- Marketing start
- 2017-02-22
- 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 |
|---|
| 68083-160-10 | Tranexamic acid | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 9 |
| 68083-160-10 | Tranexamic acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-160 | TRANEXAMIC ACID INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20210630_31462875-4941-4d50-bf0c-9675493731f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-160-10 | 68083016010 | 10 VIAL in 1 CARTON (68083-160-10) / 10 mL in 1 VIAL | 10 vial | 2017-02-22 | 0000-00-00 | No | No | Current |