Xadago (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Carton

Rx only
NDC 27505-110 -30

Xadago^® (safinamide) tablets

50 mg

Keep out of reach of children.

30 tablets

US WorldMeds™

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Carton

Rx only
NDC 27505-111 -30

Xadago^® (safinamide) tablets

100 mg

Keep out of reach of children.

30 tablets

US WorldMeds™

XADAGO safinamide mesylate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27505-110 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength safinamide mesylate (safinamide) safinamide 50 mg

Inactive Ingredients Ingredient Name Strength microcrystalline cellulose crospovidone (15 MPA.S AT 5%) magnesium stearate silicon dioxide hypromellose, unspecified polyethylene glycol 6000 titanium dioxide ferric oxide red mica

Product Characteristics Color ORANGE Score no score Shape ROUND Size 7mm Flavor Imprint Code 50 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:27505-110-30 1 BOTTLE in 1 CARTON contains a BOTTLE 1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (27505-110-30) 2 NDC:27505-110-90 1 BOTTLE in 1 CARTON contains a BOTTLE 2 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (27505-110-90) 3 NDC:27505-110-14 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 14 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (27505-110-14)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA207145 05/08/2017

XADAGO safinamide mesylate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27505-111 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength safinamide mesylate (safinamide) safinamide 100 mg

Inactive Ingredients Ingredient Name Strength microcrystalline cellulose crospovidone (15 MPA.S AT 5%) magnesium stearate silicon dioxide hypromellose, unspecified polyethylene glycol 6000 titanium dioxide ferric oxide red mica

Product Characteristics Color ORANGE Score no score Shape ROUND Size 9mm Flavor Imprint Code 100 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:27505-111-30 1 BOTTLE in 1 CARTON contains a BOTTLE 1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (27505-111-30) 2 NDC:27505-111-90 1 BOTTLE in 1 CARTON contains a BOTTLE 2 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (27505-111-90) 3 NDC:27505-111-14 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 14 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (27505-111-14)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA207145 05/08/2017

Labeler — US WorldMeds, LLC (087875626)

Establishment
Name	Address	ID/FEI	Operations
Catalent Germany Schorndorf GmbH		315732628	MANUFACTURE (27505-110), MANUFACTURE (27505-111), ANALYSIS (27505-110), ANALYSIS (27505-111), PACK (27505-110), PACK (27505-111), LABEL (27505-110), LABEL (27505-111)

Establishment
Name	Address	ID/FEI	Operations
Merck KGaA		342249299	ANALYSIS (27505-110), ANALYSIS (27505-111), API MANUFACTURE (27505-110), API MANUFACTURE (27505-111)

Establishment
Name	Address	ID/FEI	Operations
Solvias AG		480739627	ANALYSIS (27505-110), ANALYSIS (27505-111)

Establishment
Name	Address	ID/FEI	Operations
PHAST Gesellschaft fuer Pharmazeutische Qualitatsstandards mbH		331156161	ANALYSIS (27505-110), ANALYSIS (27505-111)

Establishment
Name	Address	ID/FEI	Operations
BioChem Labor fur biologische und chemische Analytik GmbH		318354230	ANALYSIS (27505-110), ANALYSIS (27505-111)

Establishment
Name	Address	ID/FEI	Operations
PRC Ticinum Lab s.r.l		437339604	ANALYSIS (27505-110), ANALYSIS (27505-111)

Revised: 12/2019 US WorldMeds, LLC