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NDC 68982-0261-02 Balfaxar 25.5; 16.5; 24; 22; 22; 26 [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL Details
Balfaxar 25.5; 16.5; 24; 22; 22; 26 [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL
Balfaxar is a INTRAVENOUS POWDER, FOR SOLUTION in the PLASMA DERIVATIVE category. It is labeled and distributed by Octapharma USA Inc. The primary component is COAGULATION FACTOR IX HUMAN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN; PROTHROMBIN.
Product Information
| NDC | 68982-0261 |
|---|---|
| Product ID | 68982-261_5be10bd2-a785-7f3b-0d28-d066cd5f7d24 |
| Associated GPIs | |
| GCN Sequence Number | 085101 |
| GCN Sequence Number Description | hum prothrombin cplx(PCC)-lans VIAL 500 UNIT INTRAVEN |
| HIC3 | M0I |
| HIC3 Description | FACTOR IX COMPLEX (PCC) PREPARATIONS |
| GCN | 54544 |
| HICL Sequence Number | 049099 |
| HICL Sequence Number Description | HUMAN PROTHROMBIN COMPLEX CONCENTRATE (PCC)-LANS |
| Brand/Generic | Brand |
| Proprietary Name | Balfaxar |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Prothrombin Complex Concentrate (Human) |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 25.5; 16.5; 24; 22; 22; 26 |
| Active Ingredient Units | [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL |
| Substance Name | COAGULATION FACTOR IX HUMAN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN; PROTHROMBIN |
| Labeler Name | Octapharma USA Inc |
| Pharmaceutical Class | Anti-coagulant [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Decreased Coagulation Factor Activity [PE], Enzyme Precursors [CS], Human |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125776 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68982-0261-02 (68982026102)
| NDC Package Code | 68982-261-02 |
|---|---|
| Billing NDC | 68982026102 |
| Package | 1 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82) |
| Marketing Start Date | 2023-11-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |