Zohydro

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Alkermes Gainesville, LLC.

Labeler

Zogenix, Inc.

DUNS Number

057585150

Products6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

43376-340

Application Number

NDA202880

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 25, 2015

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 40 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

POVIDONESInactive

Code: FZ989GH94EClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Zohydro

Product Details

NDC Product Code

43376-320

Application Number

NDA202880

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 25, 2015

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 20 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONESInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

Zohydro

Product Details

NDC Product Code

43376-315

Application Number

NDA202880

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 25, 2015

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONESInactive

Code: FZ989GH94EClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 15 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Zohydro

Product Details

NDC Product Code

43376-330

Application Number

NDA202880

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 25, 2015

Ingredients

POVIDONESInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 30 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

Zohydro

Product Details

NDC Product Code

43376-310

Application Number

NDA202880

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 25, 2015

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONESInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Zohydro

Product Details

NDC Product Code

43376-350

Application Number

NDA202880

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 25, 2015

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 50 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

POVIDONESInactive

Code: FZ989GH94EClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

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Zohydro

FDA Approval Summary

Manufacturing Establishments1

Products6

Zohydro

Product Details

Zohydro

Product Details

Zohydro

Product Details

Zohydro

Product Details

Zohydro

Product Details

Zohydro

Product Details