Hysingla ER

These highlights do not include all the information needed to use HYSINGLA ER safely and effectively. See full prescribing information for HYSINGLA ER. HYSINGLA ER (hydrocodone bitartrate) extended-release tablets, for oral use, CIIInitial U.S. Approval: 1943

Approved

Approval ID

b7d23ac2-e776-9f62-3290-c64c2d6eb353

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2023

Manufacturers

FDA

Purdue Pharma LP

DUNS: 932323652

Products 7

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 Code59011-277

Application NumberNDA206627

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2021

FDA Product Classification

INGREDIENTS (11)

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROCODONE BITARTRATEActive

Quantity: 120 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59011-275

Application NumberNDA206627

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2021

FDA Product Classification

INGREDIENTS (12)

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROCODONE BITARTRATEActive

Quantity: 80 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59011-272

Application NumberNDA206627

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2021

FDA Product Classification

INGREDIENTS (12)

HYDROCODONE BITARTRATEActive

Quantity: 30 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59011-273

Application NumberNDA206627

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2021

FDA Product Classification

INGREDIENTS (14)

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROCODONE BITARTRATEActive

Quantity: 40 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59011-271

Application NumberNDA206627

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2021

FDA Product Classification

INGREDIENTS (15)

HYDROCODONE BITARTRATEActive

Quantity: 20 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

COCHINEALInactive

Code: TZ8Z31B35M

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59011-276

Application NumberNDA206627

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2021

FDA Product Classification

INGREDIENTS (13)

HYDROCODONE BITARTRATEActive

Quantity: 100 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

hydrocodone bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59011-274

Application NumberNDA206627

Product Classification

Marketing Category

C73594

Generic Name

hydrocodone bitartrate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2021

FDA Product Classification

INGREDIENTS (13)

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

HYDROCODONE BITARTRATEActive

Quantity: 60 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

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Hysingla ER

Products 7

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

hydrocodone bitartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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