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NDC 50458-0720-30 PONVORY 20 mg/1 Details
PONVORY 20 mg/1
PONVORY is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc. The primary component is PONESIMOD.
MedlinePlus Drug Summary
Ponesimod is used to prevent episodes of symptoms and slow the worsening of disability in adults who have relapsing forms 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), including: clinically isolated syndrome (CIS; first nerve symptom episode that lasts at least 24 hours), relapsing-remitting disease (course of disease where symptoms flare up from time to time), active secondary progressive disease (later stage of disease with continuous worsening of symptoms.) Ponesimod 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: 50458-0720-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ponesimod
Product Information
| NDC | 50458-0720 |
|---|---|
| Product ID | 50458-720_031492a4-9020-b9ed-e063-6394a90a84b4 |
| Associated GPIs | 62407060000320 |
| GCN Sequence Number | 082092 |
| GCN Sequence Number Description | ponesimod TABLET 20 MG ORAL |
| HIC3 | H0E |
| HIC3 Description | AGENTS TO TREAT MULTIPLE SCLEROSIS |
| GCN | 49395 |
| HICL Sequence Number | 047221 |
| HICL Sequence Number Description | PONESIMOD |
| Brand/Generic | Brand |
| Proprietary Name | PONVORY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ponesimod |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | PONESIMOD |
| Labeler Name | Janssen Pharmaceuticals, Inc |
| Pharmaceutical Class | Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213498 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50458-0720-30 (50458072030)
| NDC Package Code | 50458-720-30 |
|---|---|
| Billing NDC | 50458072030 |
| Package | 1 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2021-03-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |