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NDC 63323-0229-30 Protamine Sulfate 10 mg/mL Details
Protamine Sulfate 10 mg/mL
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 Information
| NDC | 63323-0229 |
|---|---|
| Product ID | 63323-229_083a416a-ff54-43a2-b621-c4cf7a30b464 |
| Associated GPIs | 85500010102005 |
| GCN Sequence Number | 006570 |
| GCN Sequence Number Description | protamine sulfate VIAL 10 MG/ML INTRAVEN |
| HIC3 | M9R |
| HIC3 Description | COAGULANTS |
| GCN | 25860 |
| HICL Sequence Number | 002816 |
| HICL Sequence Number Description | PROTAMINE SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Protamine Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | PROTAMINE SULFATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | PROTAMINE SULFATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA089454 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0229-30 (63323022930)
| NDC Package Code | 63323-229-30 |
|---|---|
| Billing NDC | 63323022930 |
| Package | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-30) / 25 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2000-10-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |