NDC Code(s) : 49999-857-90, 49999-857-30, 49999-857-00
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxycontin Oxycodone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-857(NDC:59011-107)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE80 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE(UNII: FZ989GH94E)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBIC ACID(UNII: X045WJ989B)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color green Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code 80;OC
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49999-857-9090 in 1 BOTTLE, PLASTIC
2NDC:49999-857-3030 in 1 BOTTLE, PLASTIC
3NDC:49999-857-00100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020553 08/28/2010

PRINCIPAL DISPLAY PANEL

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