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
3686cde5-f76d-4d16-aa5d-caceb8408f8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
MARKSANS PHARMA LIMITED
DUNS: 925822975
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Duloxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25000-610
Application NumberANDA090723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Duloxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (15)
DULOXETINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 9044SC542W
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
Duloxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25000-608
Application NumberANDA090723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Duloxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (16)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DULOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 9044SC542W
Classification: ACTIM
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Duloxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25000-609
Application NumberANDA090723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Duloxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (14)
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
DULOXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 9044SC542W
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT