Zohydro

These highlights do not include all the information needed to use ZOHYDRO ER safely and effectively. See full prescribing information for ZOHYDRO ER. ZOHYDRO ER (hydrocodone bitartrate) extended‑release capsules, for oral use, CII Initial U.S. Approval: 1943

Approved

Approval ID

cf68f7fe-30a9-4f1a-a3a4-6352dc436bbe

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 26, 2014

Manufacturers

FDA

Zogenix, Inc.

DUNS: 867785441

Products 6

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

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43376-230

Application NumberNDA202880

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 26, 2014

FDA Product Classification

INGREDIENTS (15)

HYDROCODONE BITARTRATEActive

Quantity: 30 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43376-210

Application NumberNDA202880

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 26, 2014

FDA Product Classification

INGREDIENTS (15)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYDROCODONE BITARTRATEActive

Quantity: 10 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43376-250

Application NumberNDA202880

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 26, 2014

FDA Product Classification

INGREDIENTS (15)

HYDROCODONE BITARTRATEActive

Quantity: 50 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43376-220

Application NumberNDA202880

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 26, 2014

FDA Product Classification

INGREDIENTS (15)

HYDROCODONE BITARTRATEActive

Quantity: 20 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43376-215

Application NumberNDA202880

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 26, 2014

FDA Product Classification

INGREDIENTS (15)

HYDROCODONE BITARTRATEActive

Quantity: 15 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43376-240

Application NumberNDA202880

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 26, 2014

FDA Product Classification

INGREDIENTS (15)

HYDROCODONE BITARTRATEActive

Quantity: 40 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

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Zohydro

Products 6

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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Company

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