SPEVIGO
- Product NDC
- 50222-360
- 11-digit product format
- 502220360
- Labeler code
- 50222
- Product ID
- 50222-360_40cef378-e90e-4891-812a-b3c889dc9193
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spesolimab
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- LEO Pharma Inc.
- Application
- BLA761244
- Marketing category
- BLA
- Marketing start
- 2026-03-09
- Substance
- SPESOLIMAB
- Active strength
- 60 mg/mL
- Pharmacologic classes
- Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPEVIGO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SPESOLIMAB | 60 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 5IB2J79MCX |
| Rxcui | 2610422, 2610428, 2678979, 2678984, 2716696, 2716697 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e1c7d730-1f8a-459d-b248-0fb8a3a883af | Product name | 1 | 20230626 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50222-360-72 | SPEVIGO | 7.5 mL in 1 VIAL, GLASS | INJECTION | 7.5 | 2 | |
| 50222-360-72 | SPEVIGO | 2 in 1 CARTON | INJECTION | 2 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2678979 | spesolimab-sbzo 150 MG in 1 ML Prefilled Syringe | PSN | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2716696 | spesolimab-sbzo 300 MG in 2 ML Prefilled Syringe | PSN | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2610422 | spesolimab-sbzo 450 MG in 7.5 ML Injection | PSN | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2678984 | Spevigo 150 MG in 1 ML Prefilled Syringe | PSN | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2716697 | Spevigo 300 MG in 2 ML Prefilled Syringe | PSN | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2610428 | Spevigo 450 MG in 7.5 ML Injection | PSN | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2678984 | 1 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo] | SBD | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2716697 | 2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo] | SBD | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2610428 | 7.5 ML spesolimab-sbzo 60 MG/ML Injection [Spevigo] | SBD | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2678979 | 1 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe | SCD | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2716696 | 2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe | SCD | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2610422 | 7.5 ML spesolimab-sbzo 60 MG/ML Injection | SCD | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2678984 | 1 ML Spevigo 150 MG/ML Prefilled Syringe | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2610428 | 7.5 ML Spevigo 60 MG/ML Injection | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2678979 | spesolimab-sbzo 150 MG per 1 ML Prefilled Syringe | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2716696 | spesolimab-sbzo 300 MG per 2 ML Prefilled Syringe | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2610422 | spesolimab-sbzo 450 MG per 7.5 ML Injection | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2678984 | Spevigo 150 MG per 1 ML Prefilled Syringe | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2716697 | Spevigo 300 MG per 2 ML Prefilled Syringe | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
| 2610428 | Spevigo 450 MG per 7.5 ML Injection | SY | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50222-360-72 | 50222036072 | 2 VIAL, GLASS in 1 CARTON (50222-360-72) / 7.5 mL in 1 VIAL, GLASS | 2026-03-09 | No | No | Historical |