Atomoxetine hydrochloride
These highlights do not include all the information needed to use Atomoxetine Hydrochloride Capsules safely and effectively. See full prescribing information for Atomoxetine Hydrochloride Capsules Initial U.S. Approval: 2002
Approved
Approval ID
47137273-b9c1-4cb4-99ca-2dab9690b560
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2010
Manufacturers
FDA
Sandoz Inc
DUNS: 110342024
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atomoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2263
Application NumberANDA079018
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (11)
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Atomoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2266
Application NumberANDA079018
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (11)
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Atomoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2262
Application NumberANDA079018
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (11)
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Atomoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2264
Application NumberANDA079018
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (12)
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Atomoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2261
Application NumberANDA079018
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (11)
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 18 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Atomoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2260
Application NumberANDA079018
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Atomoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2265
Application NumberANDA079018
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (11)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT