Xyntha
- Product NDC
- 58394-025
- 11-digit product format
- 583940025
- Labeler code
- 58394
- Product ID
- 58394-025_9b1ef7a8-35e5-4b97-9907-fc807d47e0fc
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- antihemophilic factor (recombinant)
- Dosage form
- KIT
- Labeler
- Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
- Application
- BLA125264
- Marketing category
- BLA
- Marketing start
- 2011-08-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xyntha
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58394-025-03 | Xyntha | 1 in 1 CARTON | KIT | 1 | | 35 |
| 58394-125-03 | Xyntha | 4 mL in 1 SYRINGE | INJECTION, POWDER, LYOPHILIZED, | 4 mL | 2000 [iU] in 4mL | 35 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED | ACTIVE INGREDIENT | 113E3Z3CJJ | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED | ACTIVE MOIETY | 113E3Z3CJJ | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 19 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58394-025 | XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC] | 34 | Current NDC, Legacy NDC, 2 package rows | 20250119_25ea1c3c-14a2-ef11-302e-012bd683924f.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | Rx | 2026-06-01 |
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 |
|---|
| 58394-025-03 | 58394002503 | 1 KIT in 1 CARTON (58394-025-03) * 4 mL in 1 SYRINGE (58394-125-03) * 1 mL in 1 PACKET | 1 kit | 2011-08-01 | 0000-00-00 | No | No | Current |
| 58394-125-03 | 58394012503 | 4 mL in 1 SYRINGE | 4 ml | | | | | Historical |