BeneFIX
- Product NDC
- 58394-636
- 11-digit product format
- 583940636
- Labeler code
- 58394
- Product ID
- 58394-636_3b0657cb-0070-4c64-b72c-2518178805e7
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- coagulation factor ix (recombinant)
- Dosage form
- KIT
- Labeler
- Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
- Application
- BLA103677
- Marketing category
- BLA
- Marketing start
- 2007-07-06
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BeneFIX
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-1111-01 | BeneFIX | 1 mL in 1 PACKET | SWAB | 2 mL | 70 mL in 100mL | 45 |
| 58394-136-03 | BeneFIX | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 2000 [iU] in 5mL | 45 |
| 58394-636-03 | BeneFIX | 1 in 1 CARTON | KIT | 1 | | 45 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COAGULATION FACTOR IX RECOMBINANT HUMAN | ACTIVE INGREDIENT | 382L14738L | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| COAGULATION FACTOR IX RECOMBINANT HUMAN | ACTIVE MOIETY | 382L14738L | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 25 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58394-636 | BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC] | 45 | Current NDC, Legacy NDC, 3 package rows | 20250227_85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0069-1111-01 | 00069111101 | 1 mL in 1 PACKET | 1 ml | | | | | Historical |
| 58394-136-03 | 58394013603 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | | | | | Historical |
| 58394-636-03 | 58394063603 | 1 KIT in 1 CARTON (58394-636-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-136-03) | 1 kit | 2007-07-06 | 0000-00-00 | No | No | Current |