Product NDC: | 63323-229 |
Proprietary Name: | Protamine Sulfate |
Non Proprietary Name: | PROTAMINE SULFATE |
Active Ingredient(s): | 10 mg/mL & nbsp; PROTAMINE SULFATE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-229 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA089454 |
Marketing Category: | ANDA |
Start Marketing Date: | 20001018 |
Package NDC: | 63323-229-30 |
Package Description: | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-30) > 25 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 63323-229-30 |
Proprietary Name | Protamine Sulfate |
Package Description | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-30) > 25 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 63323-229 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | PROTAMINE SULFATE |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20001018 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | PROTAMINE SULFATE |
Strength Number | 10 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] |