OXYCODONE HCL- oxycodone hcl tablet 
Direct RX

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OXYCODONE HCL

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONs

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE AND ADMINISTRATION

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

OXYCODONE

OXYCODONE HCL 
oxycodone hcl tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-659(NDC:57664-187)
Route of AdministrationORALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) OXYCODONE HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorgreenScore2 pieces
ShapeROUNDSize6mm
FlavorImprint Code 187
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-659-6060 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09065902/08/2016
Labeler - Direct RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
Direct RX079254320repack(61919-659)

Revised: 2/2016
Document Id: 2b48c2dd-e62f-4f53-e054-00144ff88e88
Set id: 2b48c2dd-e62e-4f53-e054-00144ff88e88
Version: 1
Effective Time: 20160208
 
Direct RX