| 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] |