Vyvanse (Page 7 of 7)

VYVANSE®

(lisdexamfetamine dimesylate) CII

30 mg Capsules

vyvanse-30mg
(click image for full-size original)

40 mg Capsules

vyvanse-40mg
(click image for full-size original)

50 mg Capsules

vyvanse-50mg
(click image for full-size original)

70 mg Capsules

vyvanse-70mg
(click image for full-size original)
VYVANSE lisdexamfetamine dimesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5916(NDC:59417-103)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) LISDEXAMFETAMINE DIMESYLATE 30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
FD&C RED NO. 3
FD&C YELLOW NO. 6
Product Characteristics
Color white (white) , orange (orange) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code NRP104;S489;30mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5916-0 10 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5916-1 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021977 07/11/2008
VYVANSE lisdexamfetamine dimesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6009(NDC:59417-104)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) LISDEXAMFETAMINE DIMESYLATE 40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
FD&C RED NO. 3
FD&C YELLOW NO. 6
Product Characteristics
Color white (white) , green (green) , blue (blue) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code NRP104;S489;40mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6009-0 10 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-6009-1 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021977 03/20/2009
VYVANSE lisdexamfetamine dimesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5827(NDC:59417-105)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) LISDEXAMFETAMINE DIMESYLATE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
FD&C RED NO. 3
FD&C YELLOW NO. 6
Product Characteristics
Color white (white) , blue (blue) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code NRP104;S489;50mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5827-0 10 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5827-1 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021977 07/11/2008
VYVANSE lisdexamfetamine dimesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3655(NDC:59417-107)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) LISDEXAMFETAMINE DIMESYLATE 70 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
FD&C RED NO. 3
FD&C YELLOW NO. 6
Product Characteristics
Color blue (blue) , orange (orange) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code NRP104;S489;70mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3655-0 10 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-3655-1 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021977 03/04/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 01/2012 Physicians Total Care, Inc.

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