VOYXACT
- Product NDC
- 59148-400
- 11-digit product format
- 591480400
- Labeler code
- 59148
- Product ID
- 59148-400_9aa886b0-669e-48d4-9f37-a160d78f69c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sibeprenlimab
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Otsuka America Pharmaceutical, Inc.
- Application
- BLA761434
- Marketing category
- BLA
- Marketing start
- 2025-11-25
- Substance
- SIBEPRENLIMAB
- Active strength
- 200 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VOYXACT
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIBEPRENLIMAB | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GHX28QZ7DD |
| Rxcui | 2728400, 2728407 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59148-400-75 | VOYXACT | 2 mL in 1 SYRINGE | INJECTION | 2 | | 3 |
| 59148-400-75 | VOYXACT | 1 in 1 CARTON | INJECTION | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59148-400-75 | 59148040075 | 1 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGE | 1 syringe | 2025-11-25 | No | No | Current |