xadago

Generic: safinamide mesylate

Labeler: mdd us operations llc, a subsidiary of supernus pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xadago
Generic Name safinamide mesylate
Labeler mdd us operations llc, a subsidiary of supernus pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

safinamide mesylate 100 mg/1

Manufacturer
MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 27505-111
Product ID 27505-111_41c1c50d-7460-15f0-e063-6294a90a1b79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207145
Listing Expiration 2026-12-31
Marketing Start 2017-05-08

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] monoamine oxidase type b inhibitor [epc] monoamine oxidase-b inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27505111
Hyphenated Format 27505-111

Supplemental Identifiers

RxCUI
1922466 1922472 1922474 1922476
UNII
YS90V3DTX0

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xadago (source: ndc)
Generic Name safinamide mesylate (source: ndc)
Application Number NDA207145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

27505-111-14 1 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 27505-111-30 1 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE 27505-111-90 1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

safinamide mesylate (100 mg/1)

Linked Drug Pages (1)

Xadago ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41c1c50d-7460-15f0-e063-6294a90a1b79", "openfda": {"unii": ["YS90V3DTX0"], "rxcui": ["1922466", "1922472", "1922474", "1922476"], "spl_set_id": ["c4d65f28-983f-42b4-bb23-023ae0fe81b2"], "manufacturer_name": ["MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (27505-111-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "27505-111-14", "marketing_start_date": "20170508"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (27505-111-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "27505-111-30", "marketing_start_date": "20170508"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (27505-111-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "27505-111-90", "marketing_start_date": "20170508"}], "brand_name": "Xadago", "product_id": "27505-111_41c1c50d-7460-15f0-e063-6294a90a1b79", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Monoamine Oxidase Type B Inhibitor [EPC]", "Monoamine Oxidase-B Inhibitors [MoA]"], "product_ndc": "27505-111", "generic_name": "safinamide mesylate", "labeler_name": "MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xadago", "active_ingredients": [{"name": "SAFINAMIDE MESYLATE", "strength": "100 mg/1"}], "application_number": "NDA207145", "marketing_category": "NDA", "marketing_start_date": "20170508", "listing_expiration_date": "20261231"}