Prescription drug · NDA
Vyscoxa (celecoxib) NDC 15370-501
Celecoxib 10 mg/mL · Suspension · Oral · Carwin Pharmaceutical Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15370-501-16 | 15370050116 | 473 mL in 1 BOTTLE (15370-501-16)Marketed from Jul 31, 2025 |
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)
- Vyscoxa
- Generic name (nonproprietary)
- celecoxib
- Active ingredients
- Celecoxib — 10 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211759
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 15370-501_28480106-933c-452e-acfd-75e1fe7179e4SPL ID 28480106-933c-452e-acfd-75e1fe7179e4SPL set ID 5094d47e-f791-4190-9397-b7500143a74dRxCUI 2721529, 2721535UNII JCX84Q7J1L
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N415370050116followed by a unit qualifier and the quantityPackage 15370-0501-16. 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)
1. INDICATIONS AND USAGE VYSCOXA is indicated In adults for the management of the signs and symptoms of: VYSCOXA contains celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated: In adults for • Osteoarthritis (OA) ( 1.1 ) • Rheumatoid Arthritis (RA) ( 1.2 ) • Ankylosing Spondylitis (AS) ( 1.3 ) In pediatric patients two years and older for • Juvenile Rheumatoid Arthritis (JRA) ( 1.4 ) Limitations of Use VYSCOXA must be administered on an empty stomach at least 2 hours before or 1 hour after food. Taking VYSCOXA with food results in plasma exposures of celecoxib up to 50% higher than intended. If patients cannot tolerate VYSCOXA in the fasted state, discontinue use of VYSCOXA ( 2.…
Excerpt only. Read the full label for complete information.