NDC Code(s) : 49999-889-30, 49999-889-90
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SimvastatinSimvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-889(NDC:65862-052)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV) 		SIMVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color pink (Light Pink) Score no score
Shape ROUND (Biconvex) Size 8 mm
Flavor Imprint Code A;02
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49999-889-3030 in 1 BOTTLE Type 0: Not a Combination Product22/11/2011
2NDC:49999-889-9090 in 1 BOTTLE Type 0: Not a Combination Product22/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077691 11/22/2011

PRINCIPAL DISPLAY PANEL

image of labelIMAGE OF LABEL