NDC Code(s) : 35356-751-30, 35356-751-60, 35356-751-90
Packager : Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Vyvanselisdexamfetamine dimesylate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-751(NDC:59417-102)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISDEXAMFETAMINE DIMESYLATE(UNII: SJT761GEGS)
(LISDEXAMFETAMINE - UNII:H645GUL8KJ) 		LISDEXAMFETAMINE DIMESYLATE20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 15 mm
Flavor Imprint Code NRP104;S489;20mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-751-3030 in 1 BOTTLE
2NDC:35356-751-6060 in 1 BOTTLE
3NDC:35356-751-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021977 12/10/2007

PRINCIPAL DISPLAY PANEL

Image of Label