Sertraline Hydrochloride
SERTRALINE HYDROCHLORIDE TABLETS Rx only
Approved
Approval ID
c25f968b-7037-4f60-9a02-2189769b0cbf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2016
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sertraline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-167
Application NumberANDA077977
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sertraline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2014
FDA Product Classification
INGREDIENTS (10)
SERTRALINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Sertraline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-164
Application NumberANDA077977
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sertraline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2014
FDA Product Classification
INGREDIENTS (10)
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Sertraline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-168
Application NumberANDA077977
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sertraline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2014
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Sertraline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-166
Application NumberANDA077977
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sertraline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2014
FDA Product Classification
INGREDIENTS (10)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Sertraline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-165
Application NumberANDA077977
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sertraline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2014
FDA Product Classification
INGREDIENTS (10)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SERTRALINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT