Product NDC: | 63323-563 |
Proprietary Name: | Tranexamic Acid |
Non Proprietary Name: | Tranexamic Acid |
Active Ingredient(s): | 100 mg/mL & nbsp; Tranexamic Acid |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-563 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA202373 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120420 |
Package NDC: | 63323-563-97 |
Package Description: | 10 AMPULE in 1 BOX (63323-563-97) > 10 mL in 1 AMPULE |
NDC Code | 63323-563-97 |
Proprietary Name | Tranexamic Acid |
Package Description | 10 AMPULE in 1 BOX (63323-563-97) > 10 mL in 1 AMPULE |
Product NDC | 63323-563 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Tranexamic Acid |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20120420 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | TRANEXAMIC ACID |
Strength Number | 100 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] |