Olanzapine and Fluoxetine

These highlights do not include all the information needed to use OLANZAPINE AND FLUOXETINE CAPSULES safely and effectively. See full prescribing information for OLANZAPINE AND FLUOXETINE CAPSULES. OLANZAPINE and FLUOXETINE CAPSULES, for oral use. Initial U.S. Approval: 2003

Approved

Approval ID

2f6ceda3-3edc-4427-98a6-23e3c930c44d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 29, 2024

Manufacturers

FDA

Par Pharmaceutical, Inc.

DUNS: 092733690

Products 5

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

olanzapine and fuoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-277

Application NumberANDA077742

Product Classification

Marketing Category

C73584

Generic Name

olanzapine and fuoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 29, 2024

FDA Product Classification

INGREDIENTS (17)

OLANZAPINEActive

Quantity: 3 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

FLUOXETINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: I9W7N6B1KJ

Classification: ACTIM

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

olanzapine and fuoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-252

Application NumberANDA077742

Product Classification

Marketing Category

C73584

Generic Name

olanzapine and fuoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 29, 2024

FDA Product Classification

INGREDIENTS (18)

OLANZAPINEActive

Quantity: 12 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FLUOXETINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: I9W7N6B1KJ

Classification: ACTIM

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

olanzapine and fuoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-251

Application NumberANDA077742

Product Classification

Marketing Category

C73584

Generic Name

olanzapine and fuoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 29, 2024

FDA Product Classification

INGREDIENTS (18)

OLANZAPINEActive

Quantity: 6 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

FLUOXETINE HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: I9W7N6B1KJ

Classification: ACTIM

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

olanzapine and fuoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-253

Application NumberANDA077742

Product Classification

Marketing Category

C73584

Generic Name

olanzapine and fuoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 29, 2024

FDA Product Classification

INGREDIENTS (19)

OLANZAPINEActive

Quantity: 12 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

FLUOXETINE HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: I9W7N6B1KJ

Classification: ACTIM

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

olanzapine and fuoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-250

Application NumberANDA077742

Product Classification

Marketing Category

C73584

Generic Name

olanzapine and fuoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 29, 2024

FDA Product Classification

INGREDIENTS (16)

OLANZAPINEActive

Quantity: 6 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

FLUOXETINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: I9W7N6B1KJ

Classification: ACTIM

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

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Olanzapine and Fluoxetine

Products 5

olanzapine and fuoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

olanzapine and fuoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

olanzapine and fuoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

olanzapine and fuoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

olanzapine and fuoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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