SABRIL (Page 11 of 11)

PRINCIPAL DISPLAY PANEL
NDC 67386-111-01
Sabril®
(vigabatrin) Tablets
500 mg
DISPENSE THE ENCLOSED MEDICATION
GUIDE WITH EACH PRESCTIPTION.
Rx only100 Tablets

PRINCIPAL DISPLAY PANEL NDC 67386-111-01 Sabril® (vigabatrin) Tablets 500 mg DISPENSE THE ENCLOSED MEDICATION GUIDE WITH EACH PRESCTIPTION. Rx only 100 Tablets
(click image for full-size original)

SABRIL vigabatrin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67386-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VIGABATRIN (VIGABATRIN) VIGABATRIN 500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POVIDONE
TITANIUM DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code OV;111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67386-111-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020427 08/21/2009
Labeler — Lundbeck LLC (018343595)
Establishment
Name Address ID/FEI Operations
Patheon Pharmaceuticals Inc. 005286822 ANALYSIS (67386-111), MANUFACTURE (67386-111)
Establishment
Name Address ID/FEI Operations
Sanofi Aventis SPA 378937457 API MANUFACTURE (67386-111)

Revised: 06/2016 Lundbeck LLC

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