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NDC 27505-0111-90 Xadago 100 mg/1 Details
Xadago 100 mg/1
Xadago is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.. The primary component is SAFINAMIDE MESYLATE.
MedlinePlus Drug Summary
Safinamide is used along with the combination of levodopa and carbidopa (Duopa, Rytary, Sinemet, others) to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen as medication wears off or at random) in people with Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Safinamide is in a group of medications called monoamine oxidase type B (MAO-B) inhibitors. It works by increasing the amount of dopamine (a natural substance that is needed to control movement) in the brain.
Related Packages: 27505-0111-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Safinamide
Product Information
| NDC | 27505-0111 |
|---|---|
| Product ID | 27505-111_0cf4e97f-18de-5426-e063-6294a90ac4b0 |
| Associated GPIs | 73300028200330 |
| GCN Sequence Number | 075079 |
| GCN Sequence Number Description | safinamide mesylate TABLET 100 MG ORAL |
| HIC3 | H6A |
| HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
| GCN | 40008 |
| HICL Sequence Number | 042752 |
| HICL Sequence Number Description | SAFINAMIDE MESYLATE |
| Brand/Generic | Brand |
| Proprietary Name | Xadago |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | safinamide mesylate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | SAFINAMIDE MESYLATE |
| Labeler Name | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA207145 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 27505-0111-90 (27505011190)
| NDC Package Code | 27505-111-90 |
|---|---|
| Billing NDC | 27505011190 |
| Package | 1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2017-05-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |