Duloxetine

These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval: 2004

Approved

Approval ID

f61bd9f3-cd3d-4c76-a110-0f1dcba610af

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 6, 2023

Manufacturers

FDA

Asclemed USA, Inc.

DUNS: 059888437

Products 4

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

Duloxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code76420-636

Application NumberANDA208706

Product Classification

Marketing Category

C73584

Generic Name

Duloxetine

Product Specifications

Route of AdministrationORAL

Effective DateNovember 6, 2023

FDA Product Classification

INGREDIENTS (19)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

DULOXETINE HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: 9044SC542W

Classification: ACTIM

Duloxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code76420-633

Application NumberANDA208706

Product Classification

Marketing Category

C73584

Generic Name

Duloxetine

Product Specifications

Route of AdministrationORAL

Effective DateNovember 6, 2023

FDA Product Classification

INGREDIENTS (18)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

DULOXETINE HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 9044SC542W

Classification: ACTIM

WATERInactive

Code: 059QF0KO0R

Classification: IACT

Duloxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code76420-634

Application NumberANDA208706

Product Classification

Marketing Category

C73584

Generic Name

Duloxetine

Product Specifications

Route of AdministrationORAL

Effective DateNovember 6, 2023

FDA Product Classification

INGREDIENTS (18)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DULOXETINE HYDROCHLORIDEActive

Quantity: 30 mg in 1 1

Code: 9044SC542W

Classification: ACTIM

Duloxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code76420-623

Application NumberANDA208706

Product Classification

Marketing Category

C73584

Generic Name

Duloxetine

Product Specifications

Route of AdministrationORAL

Effective DateNovember 6, 2023

FDA Product Classification

INGREDIENTS (18)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DULOXETINE HYDROCHLORIDEActive

Quantity: 60 mg in 1 1

Code: 9044SC542W

Classification: ACTIM

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

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Duloxetine

Products 4

Duloxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Duloxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Duloxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Duloxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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