Atomoxetine
These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES. ATOMOXETINE capsules, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
10d36b32-0202-4c03-8a1a-cd5d53f231e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 2
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 Code60687-326
Application NumberANDA079016
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (10)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Atomoxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-567
Application NumberANDA079016
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atomoxetine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (10)
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIM