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 — 50 mg Tablet Bottle Label

Bottle Label

Rx only
NDC 27505- 110-30

Xadago ® (safinamide) tablets

50 mg

Keep out of reach of children.

30 tablets

US WorldMeds™

Bottle-Label-Xadago-50mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50mg Shipper Label

SHIPPING LABEL

Product: Xadago 50mg OP 30 USA

Label Item Number: PCD4454785ZAMBON

Label Version Number: 454785-V001

Batch No:

Expiry Date:

Item-no.:

Outer box No.:

Number of finished packs per outer: 24

SHIPPED TO:

ZAMBON

SHIPPED FROM:

Catalent Germany Schorndorf GmBH

Shipper-Label Xadago-50mg
(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)

PRINCIPAL DISPLAY PANEL — 100mg Tablet Bottle Label

Bottle Label

Rx only
NDC 27505- 111-30

Xadago ® (safinamide) tablets

100 mg

Keep out of reach of children.

30 tablets

US WorldMeds™

Bottle-Label-Xadago-100mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100mg Shipper Label

SHIPPING LABEL

Product: Xadago 100mg OP 30 USA

Label Item Number: PCD4454838ZAMBON

Label Version Number: 454838k-V001

Batch No:

Expiry date:

Item-no.: D191923

Outer Box No.:

Number of finished packs per outer: 24

Shipper-Label-Xadago-100
(click image for full-size original)
XADAGO safinamide mesylate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68621-0030
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:68621-0030-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68621-0030-1)
2 NDC:68621-0030-2 1 BOTTLE in 1 CARTON contains a BOTTLE
2 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68621-0030-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA207145 05/08/2017
XADAGO safinamide mesylate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68621-0031
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:68621-0031-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68621-0031-1)
2 NDC:68621-0031-2 1 BOTTLE in 1 CARTON contains a BOTTLE
2 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68621-0031-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207145 05/08/2017
Labeler — Catalent Germany Schorndorf GmbH (315732628)
Establishment
Name Address ID/FEI Operations
Catalent Germany Schorndorf GmbH 315732628 manufacture (68621-0030), pack (68621-0030), label (68621-0030), manufacture (68621-0031), pack (68621-0031), label (68621-0031)

Revised: 01/2018 Catalent Germany Schorndorf GmbH

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