Protamine Sulfate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Protamine Sulfate.
| Product ID | 63323-229_12d7e6bf-3191-4d6d-836b-1669ca3c95ec |
| NDC | 63323-229 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Protamine Sulfate |
| Generic Name | Protamine Sulfate |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA089454 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | PROTAMINE SULFATE |
| Active Ingredient Strength | 10 mg/mL |
| Pharm Classes | Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2000-10-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-06-11 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-06-11 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2000-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2000-10-18 |
| Ingredient | Strength |
|---|---|
| PROTAMINE SULFATE | 10 mg/mL |
| SPL SET ID: | 8df0a819-9e1a-44ce-97a6-3ea82c867d44 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 51662-1414 | PROTAMINE SULFATE | PROTAMINE SULFATE |
| 63323-229 | Protamine Sulfate | PROTAMINE SULFATE |