Atomoxetine

These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES. ATOMOXEITNE capsules, for oral use Initial U.S. Approval: 2002

Approved

Approval ID

973bdc9b-6421-7e00-e2b6-3cce036d363e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 24, 2022

Manufacturers

FDA

Dr. Reddy's Laboratories Limited

DUNS: 650562841

Products 7

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

Atomoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-563

Application NumberANDA090609

Product Classification

Marketing Category

C73584

Generic Name

Atomoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (17)

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

Atomoxetine HydrochlorideActive

Quantity: 80 mg in 1 1

Code: 57WVB6I2W0

Classification: ACTIM

dimethiconeInactive

Code: 92RU3N3Y1O

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

gelatinInactive

Code: 2G86QN327L

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

Atomoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-521

Application NumberANDA090609

Product Classification

Marketing Category

C73584

Generic Name

Atomoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (16)

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

gelatinInactive

Code: 2G86QN327L

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

Atomoxetine HydrochlorideActive

Quantity: 40 mg in 1 1

Code: 57WVB6I2W0

Classification: ACTIM

dimethiconeInactive

Code: 92RU3N3Y1O

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Atomoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-564

Application NumberANDA090609

Product Classification

Marketing Category

C73584

Generic Name

Atomoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (17)

Atomoxetine HydrochlorideActive

Quantity: 100 mg in 1 1

Code: 57WVB6I2W0

Classification: ACTIM

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

gelatinInactive

Code: 2G86QN327L

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

dimethiconeInactive

Code: 92RU3N3Y1O

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

Atomoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-528

Application NumberANDA090609

Product Classification

Marketing Category

C73584

Generic Name

Atomoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (16)

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

dimethiconeInactive

Code: 92RU3N3Y1O

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

Atomoxetine HydrochlorideActive

Quantity: 25 mg in 1 1

Code: 57WVB6I2W0

Classification: ACTIM

gelatinInactive

Code: 2G86QN327L

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

Atomoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-522

Application NumberANDA090609

Product Classification

Marketing Category

C73584

Generic Name

Atomoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (16)

Atomoxetine HydrochlorideActive

Quantity: 60 mg in 1 1

Code: 57WVB6I2W0

Classification: ACTIM

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

dimethiconeInactive

Code: 92RU3N3Y1O

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

gelatinInactive

Code: 2G86QN327L

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

Atomoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-520

Application NumberANDA090609

Product Classification

Marketing Category

C73584

Generic Name

Atomoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (16)

dimethiconeInactive

Code: 92RU3N3Y1O

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

Atomoxetine HydrochlorideActive

Quantity: 18 mg in 1 1

Code: 57WVB6I2W0

Classification: ACTIM

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

gelatinInactive

Code: 2G86QN327L

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

Atomoxetine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55111-519

Application NumberANDA090609

Product Classification

Marketing Category

C73584

Generic Name

Atomoxetine

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 24, 2022

FDA Product Classification

INGREDIENTS (16)

dimethiconeInactive

Code: 92RU3N3Y1O

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Atomoxetine HydrochlorideActive

Quantity: 10 mg in 1 1

Code: 57WVB6I2W0

Classification: ACTIM

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

gelatinInactive

Code: 2G86QN327L

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

ferrosoferric oxideInactive

Code: XM0M87F357

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

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Atomoxetine

Products 7

Atomoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Atomoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Atomoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Atomoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Atomoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Atomoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Atomoxetine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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