Prescription drug · BLA
Spevigo (Spesolimab-sbzo) NDC 0597-7705
Spesolimab 300 mg/1 · Injection · Intravenous · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-7705-41 | 00597770541 | 1 SYRINGE in 1 CARTON (0597-7705-41) / 300 INJECTION in 1 SYRINGE (0597-7705-38)Marketed from May 28, 2025 | |
| 0597-7705-72 | 00597770572 | 2 SYRINGE in 1 CARTON (0597-7705-72) / 300 INJECTION in 1 SYRINGE (0597-7705-38)Marketed from May 28, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Spevigo
- Generic name (nonproprietary)
- spesolimab-sbzo
- Active ingredients
- Spesolimab — 300 mg/1
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761244
- Marketing start
- Marketing end
- Other FDA classes
- Interleukin-36 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0597-7705_021b29b5-64ea-411e-91a8-c1f5015c3d9cSPL ID 021b29b5-64ea-411e-91a8-c1f5015c3d9cSPL set ID 41a481ee-3062-45d1-aed5-17e8b105634dRxCUI 2610422, 2610428, 2678979, 2678984, 2716696, 2716697UNII 5IB2J79MCXUPC 0305970035107
- Pharmacologic class
- Interleukin-36 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400597770541followed by a unit qualifier and the quantityPackage 00597-7705-41. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0597-7705
- What is NDC 0597-7705?
- 0597-7705 is the product NDC for Spevigo (spesolimab-sbzo), Spesolimab 300 mg/1 injection, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spevigo (Spesolimab-sbzo).
- What is the active ingredient?
- Spesolimab.
- Who is the labeler?
- Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spevigo?
- 5 other product NDCs are listed under this name. See all Spevigo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spevigo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spevigospesolimab | Spesolimab 60 mg/mL | InjectionSubcutaneous | LEO Pharma Inc. | 50222-360 | 50222-0360-72 |
| Spevigospesolimab | Spesolimab 150 mg/mL | InjectionSubcutaneous | LEO Pharma Inc. | 50222-361 | 50222-0361-02 |
| Spevigospesolimab | Spesolimab 300 mg/2mL | InjectionSubcutaneous | LEO Pharma Inc. | 50222-362 | 50222-0362-0150222-0362-02 |
| Spevigospesolimab-sbzo | Spesolimab 150 mg/1 | InjectionIntravenous | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0620 | 00597-0620-20 |
| Spevigospesolimab-sbzo | Spesolimab 60 mg/mL | InjectionIntravenous | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0035 | 00597-0035-10 |
Other NDCs under BLA 761244
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Spevigospesolimab-sbzo | Spesolimab 60 mg/mL | InjectionIntravenous | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0035 |
| Spevigospesolimab-sbzo | Spesolimab 150 mg/1 | InjectionIntravenous | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0620 |
| Spevigospesolimab | Spesolimab 60 mg/mL | InjectionSubcutaneous | LEO Pharma Inc. | 50222-360 |
| Spevigospesolimab | Spesolimab 150 mg/mL | InjectionSubcutaneous | LEO Pharma Inc. | 50222-361 |
| Spevigospesolimab | Spesolimab 300 mg/2mL | InjectionSubcutaneous | LEO Pharma Inc. | 50222-362 |