| Product NDC: | 58394-003 |
| Proprietary Name: | BeneFIX |
| Non Proprietary Name: | coagulation factor ix (recombinant) |
| Active Ingredient(s): | & nbsp; coagulation factor ix (recombinant) |
| Administration Route(s): | |
| Dosage Form(s): | KIT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58394-003 |
| Labeler Name: | Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer |
| Product Type: | PLASMA DERIVATIVE |
| FDA Application Number: | BLA103677 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19970201 |
| Package NDC: | 58394-003-06 |
| Package Description: | 1 KIT in 1 CARTON (58394-003-06) * 5 mL in 1 SYRINGE (58394-020-01) * 1 SWAB in 1 PACKET * 5 mL in 1 VIAL, SINGLE-USE (58394-103-06) |
| NDC Code | 58394-003-06 |
| Proprietary Name | BeneFIX |
| Package Description | 1 KIT in 1 CARTON (58394-003-06) * 5 mL in 1 SYRINGE (58394-020-01) * 1 SWAB in 1 PACKET * 5 mL in 1 VIAL, SINGLE-USE (58394-103-06) |
| Product NDC | 58394-003 |
| Product Type Name | PLASMA DERIVATIVE |
| Non Proprietary Name | coagulation factor ix (recombinant) |
| Dosage Form Name | KIT |
| Route Name | |
| Start Marketing Date | 19970201 |
| Marketing Category Name | BLA |
| Labeler Name | Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer |
| Substance Name | |
| Strength Number | |
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