Prescription drug · BLA
Simponi Aria (golimumab) NDC 57894-350
Golimumab 50 mg/4mL · Solution · Intravenous · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-350-01 | 57894035001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 19, 2013 | |
| 57894-350-89 | 57894035089 | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 19, 2013 · Sample package |
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)
- Simponi Aria
- Generic name (nonproprietary)
- golimumab
- Active ingredients
- Golimumab — 50 mg/4mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- Janssen Biotech, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125433
- Marketing start
- Listing expires
- Other FDA classes
- Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
- Identifiers
- Product ID 57894-350_3e5ed294-188e-d226-e063-6394a90a5326SPL ID 3e5ed294-188e-d226-e063-6394a90a5326SPL set ID 9e260a47-55af-4c92-8d88-a86ccc767fffRxCUI 1431642, 1431647UNII 91X1KLU43E
- Pharmacologic class
- Tumor Necrosis Factor Blocker
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
N457894035001followed by a unit qualifier and the quantityPackage 57894-0350-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2 ) Adult patients with active Ankylosing Spondylitis (AS) ( 1.3 ) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older ( 1.4 ) 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Psoriatic Arthritis (PsA) SIMPONI ARIA is indicated for the…
Excerpt only. Read the full label for complete information.