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NDC 00078-0979-12 MAYZENT 0.25 mg/1 Details
MAYZENT 0.25 mg/1
MAYZENT is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is SIPONIMOD.
MedlinePlus Drug Summary
Siponimod is used to prevent episodes of symptoms and slow the worsening of disability in adults with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Siponimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.
Related Packages: 00078-0979-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Siponimod
Product Information
| NDC | 00078-0979 |
|---|---|
| Product ID | 0078-0979_27b099c3-3ed4-4b97-8fd2-90e6f914db61 |
| Associated GPIs | 6240707020B720 62407070200320 6240707020B710 |
| GCN Sequence Number | 079603 |
| GCN Sequence Number Description | siponimod TAB DS PK 0.25MG(12) ORAL |
| HIC3 | H0E |
| HIC3 Description | AGENTS TO TREAT MULTIPLE SCLEROSIS |
| GCN | 46135 |
| HICL Sequence Number | 045670 |
| HICL Sequence Number Description | SIPONIMOD |
| Brand/Generic | Brand |
| Proprietary Name | MAYZENT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | siponimod |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/1 |
| Substance Name | SIPONIMOD |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209884 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0979-12 (00078097912)
| NDC Package Code | 0078-0979-12 |
|---|---|
| Billing NDC | 00078097912 |
| Package | 12 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-12) |
| Marketing Start Date | 2019-03-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |