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 -- 50 mg Tablet Bottle Carton
(click image for full-size original)

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™

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Carton
(click image for full-size original)
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

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