Prescription drug · NDA
Mayzent (Siponimod) NDC 0078-1014
Siponimod 1 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1014-15 | 00078101415 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1014-15)Marketed from Mar 1, 2022 | |
| 0078-1014-93 | 00078101493 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1014-93)Marketed from Mar 1, 2022 · Sample package |
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)
- Mayzent
- Generic name (nonproprietary)
- siponimod
- Active ingredients
- Siponimod — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209884
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 0078-1014_b1cddf74-1357-4177-b8be-46414241b941SPL ID b1cddf74-1357-4177-b8be-46414241b941SPL set ID 44492772-5aed-4627-bd85-e8e89f308bb3RxCUI 2121090, 2121096, 2121098, 2121100, 2123313, 2123314, 2594606, 2594608, 2594796, 2594797UNII RR6P8L282I
- Pharmacologic class
- Sphingosine 1-phosphate Receptor Modulator
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
N400078101415followed by a unit qualifier and the quantityPackage 00078-1014-15. 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)
MAYZENT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MAYZENT is a sphingosine 1-phosphate (S1P) receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Excerpt only. Read the full label for complete information.
About NDC 0078-1014
- What is NDC 0078-1014?
- 0078-1014 is the product NDC for Mayzent (siponimod), Siponimod 1 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mayzent (Siponimod).
- What is the active ingredient?
- Siponimod.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mayzent?
- 2 other product NDCs are listed under this name. See all Mayzent NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mayzent products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mayzentsiponimod | Siponimod .25 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0979 | 00078-0979-1200078-0979-5000078-0979-89+1 more |
| Mayzentsiponimod | Siponimod 2 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0986 | 00078-0986-1500078-0986-4500078-0986-93+1 more |
Other NDCs under NDA 209884
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 |
|---|---|---|---|---|
| Mayzentsiponimod | Siponimod .25 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0979 |
| Mayzentsiponimod | Siponimod 2 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0986 |