TRANEXAMIC ACID IN SODIUM CHLORIDE
- Product NDC
- 68083-613
- 11-digit product format
- 680830613
- Labeler code
- 68083
- Product ID
- 68083-613_71e0764f-b584-49fb-ba62-11f3fb32d3fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRANEXAMIC ACID
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218599
- Marketing category
- ANDA
- Marketing start
- 2024-04-16
- 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 |
|---|
| 68083-613-10 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
| 68083-613-10 | TRANEXAMIC ACID IN SODIUM CHLORIDE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-613 | TRANEXAMIC ACID IN SODIUM CHLORIDE (TRANEXAMIC ACID) INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, 2 package rows | 20240420_f06f07de-bedf-4b37-b15e-0959e0a154e6.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 |
|---|
| 68083-613-10 | 68083061310 | 10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 10 pouch | 2024-04-16 | No | No | Current |