Prescription drug · BLA
Sylvant (Siltuximab) NDC 73090-420
Siltuximab 100 mg/1 · Injection, Powder, For solution · Intravenous · Recordati Rare Diseases, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73090-420-01 | 73090042001 | 1 VIAL, SINGLE-DOSE in 1 BOX (73090-420-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Apr 23, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Sylvant
- Generic name (nonproprietary)
- siltuximab
- Active ingredients
- Siltuximab — 100 mg/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Recordati Rare Diseases, Inc.NDC labeler code 73090
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125496
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-6 Antagonists (Mechanism)
- Identifiers
- Product ID 73090-420_c32bb83e-f9f4-4a6e-928a-f736138996b6SPL ID c32bb83e-f9f4-4a6e-928a-f736138996b6SPL set ID 8d663642-f52e-49c0-a023-2da083fdfc0bRxCUI 1658132, 1658135, 1658139, 1658141UNII T4H8FMA7IM
- Pharmacologic class
- Interleukin-6 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
N473090042001followed by a unit qualifier and the quantityPackage 73090-0420-01. 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)
SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. ( 1 ) Limitations of Use SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study. Limitations of Use SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positi…
Excerpt only. Read the full label for complete information.
About NDC 73090-420
- What is NDC 73090-420?
- 73090-420 is the product NDC for Sylvant (siltuximab), Siltuximab 100 mg/1 injection, powder, for solution, listed with the FDA by Recordati Rare Diseases, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sylvant (Siltuximab).
- What is the active ingredient?
- Siltuximab.
- Who is the labeler?
- Recordati Rare Diseases, Inc., NDC labeler code 73090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sylvant?
- 1 other product NDC are listed under this name. See all Sylvant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sylvant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sylvantsiltuximab | Siltuximab 400 mg/1 | Injection, Powder, For solutionIntravenous | Recordati Rare Diseases, Inc. | 73090-421 | 73090-0421-01 |
Other NDCs under BLA 125496
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 |
|---|---|---|---|---|
| Sylvantsiltuximab | Siltuximab 400 mg/1 | Injection, Powder, For solutionIntravenous | Recordati Rare Diseases, Inc. | 73090-421 |