TRANEXAMIC ACID
- Product NDC
- 51662-1532
- 11-digit product format
- 516621532
- Labeler code
- 51662
- Product ID
- 51662-1532_1035853c-6cb9-76b2-e063-6394a90a3938
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRANEXAMIC ACID
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA205035
- Marketing category
- ANDA
- Marketing start
- 2021-06-20
- 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 |
|---|
| 51662-1532-1 | TRANEXAMIC ACID | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 51662-1532-2 | TRANEXAMIC ACID | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 51662-1532-2 | TRANEXAMIC ACID | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 3 |
| 51662-1532-3 | TRANEXAMIC ACID | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1532 | TRANEXAMIC ACID INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240201_c53e2b38-6c49-acae-e053-2995a90ae9df.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 |
|---|
| 51662-1532-1 | 51662153201 | 10 mL in 1 VIAL, SINGLE-DOSE (51662-1532-1) | 10 ml | 2021-06-20 | 0000-00-00 | No | No | Current |
| 51662-1532-2 | 51662153202 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 51662-1532-3 | 51662153203 | 10 POUCH in 1 CASE (51662-1532-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2) / 10 mL in 1 VIAL, SINGLE-DOSE | 10 pouch | 2021-06-20 | 0000-00-00 | No | No | Current |