TRANEXAMIC ACID IN SODIUM CHLORIDE
- Product NDC
- 80830-2329
- 11-digit product format
- 808302329
- Labeler code
- 80830
- Product ID
- 80830-2329_0793fd3b-1fa1-4ef3-ae2f-756ef19ecc56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals Private Limited
- Application
- ANDA217155
- Marketing category
- ANDA
- Marketing start
- 2023-10-23
- 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 |
|---|
| 80830-2329-2 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 8 |
| 80830-2329-2 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 8 |
| 80830-2329-3 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 8 |
| 80830-2329-3 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 8 |
| 80830-2329-4 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 80830-2329-5 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 1 |
| 80830-2329-5 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80830-2329 | TRANEXAMIC ACID IN SODIUM CHLORIDE (TRANEXAMIC ACID) INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] | 8 | Current NDC, 4 package rows | 20250522_c1a38ece-2050-42ea-b9de-cae3e416c59d.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 |
|---|
| 80830-2329-2 | 80830232902 | 10 POUCH in 1 CARTON (80830-2329-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 10 pouch | 2023-10-23 | No | No | Current |
| 80830-2329-3 | 80830232903 | 12 POUCH in 1 CARTON (80830-2329-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 12 pouch | 2024-01-08 | No | No | Current |
| 80830-2329-4 | 80830232904 | 10 POUCH in 1 CARTON (80830-2329-4) / 1 BAG in 1 POUCH (80830-2329-5) / 100 mL in 1 BAG | 10 pouch | 2025-07-09 | No | No | Current |
| 80830-2329-5 | 80830232905 | 1 in 1 POUCH | | | | | Historical |