Tranexamic Acid
- Product NDC
- 60505-6169
- 11-digit product format
- 605056169
- Labeler code
- 60505
- Product ID
- 60505-6169_9002dad4-1b99-59ce-1c71-810a1821f0d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Apotex Corp.
- Application
- ANDA209860
- Marketing category
- ANDA
- Marketing start
- 2020-08-05
- 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 |
|---|
| 60505-6169-1 | Tranexamic Acid | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 11 |
| 60505-6169-1 | Tranexamic Acid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6169 | TRANEXAMIC ACID (TRANEXAMIC ACID) INJECTION, SOLUTION [APOTEX CORP.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241003_a93d6ef3-e160-db0d-142f-9b91af8d8428.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 |
|---|
| 60505-6169-1 | 60505616901 | 10 VIAL in 1 CARTON (60505-6169-1) / 10 mL in 1 VIAL | 10 vial | 2020-08-05 | 0000-00-00 | No | No | Current |