hydromorphone hydrochloride

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CIIInitial U.S. Approval: 1984

Approved

Approval ID

90bda45c-9dbe-4ed5-91d0-df8446ad7026

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 25, 2023

Manufacturers

FDA

XLCare Pharmaceuticals, Inc.

DUNS: 080991142

Products 4

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

hydromorphone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72865-170

Application NumberANDA212133

Product Classification

Marketing Category

C73584

Generic Name

hydromorphone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 22, 2023

FDA Product Classification

INGREDIENTS (14)

HYDROMORPHONE HYDROCHLORIDEActive

Quantity: 16 mg in 1 1

Code: L960UP2KRW

Classification: ACTIB

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

hydromorphone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72865-168

Application NumberANDA212133

Product Classification

Marketing Category

C73584

Generic Name

hydromorphone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 22, 2023

FDA Product Classification

INGREDIENTS (14)

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYDROMORPHONE HYDROCHLORIDEActive

Quantity: 8 mg in 1 1

Code: L960UP2KRW

Classification: ACTIB

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

hydromorphone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72865-171

Application NumberANDA212133

Product Classification

Marketing Category

C73584

Generic Name

hydromorphone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 22, 2023

FDA Product Classification

INGREDIENTS (16)

HYDROMORPHONE HYDROCHLORIDEActive

Quantity: 32 mg in 1 1

Code: L960UP2KRW

Classification: ACTIB

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

hydromorphone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72865-169

Application NumberANDA212133

Product Classification

Marketing Category

C73584

Generic Name

hydromorphone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 22, 2023

FDA Product Classification

INGREDIENTS (14)

HYDROMORPHONE HYDROCHLORIDEActive

Quantity: 12 mg in 1 1

Code: L960UP2KRW

Classification: ACTIB

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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hydromorphone hydrochloride

Products 4

hydromorphone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

hydromorphone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

hydromorphone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

hydromorphone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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