OXYCODONE HYDROCHLORIDE

Manufacturing Establishments (3)

Anderson Packaging, Inc

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

053217022

Purdue Pharmaceuticals L.P.

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

132080875

Sharp Packaging Solutions

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

143696495

Products (7)

NDC Product Code

0115-1561

Application Number

NDA022272

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 19, 2019

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 60 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

OXYCODONE HYDROCHLORIDE

NDC Product Code

0115-1557

Application Number

NDA022272

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 19, 2019

Ingredients

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 15 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

OXYCODONE HYDROCHLORIDE

NDC Product Code

0115-1559

Application Number

NDA022272

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 19, 2019

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 30 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

OXYCODONE HYDROCHLORIDE

NDC Product Code

0115-1562

Application Number

NDA022272

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 19, 2019

Ingredients

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 80 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

OXYCODONE HYDROCHLORIDE

NDC Product Code

0115-1560

Application Number

NDA022272

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 19, 2019

Ingredients

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 40 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

OXYCODONE HYDROCHLORIDE

NDC Product Code

0115-1558

Application Number

NDA022272

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 19, 2019

Ingredients

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 20 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

OXYCODONE HYDROCHLORIDE

NDC Product Code

0115-1556

Application Number

NDA022272

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 19, 2019

Ingredients

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 10 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

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OXYCODONE HYDROCHLORIDE

Manufacturing Establishments (3)

Products (7)

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE