NDC 49999-889-30
API & Excipient Details

Simvastatin marketed by Lake Erie Medical DBA Quality Care Products LLC under NDC Code 49999-889-30

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SIMVASTATIN(UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)	SIMVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49999-889-30	30 in 1 BOTTLE Type 0: Not a Combination Product	22/11/2011
2	NDC:49999-889-90	90 in 1 BOTTLE Type 0: Not a Combination Product	22/11/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077691	11/22/2011

PRINCIPAL DISPLAY PANEL