IMITREX
IMITREX ( sumatriptan succinate ) Tablets
Approved
Approval ID
040abcc1-cc1c-4f00-b302-36070611f7b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sumatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5118
Application NumberNDA020132
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2012
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
sumatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3777
Application NumberNDA020132
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2012
FDA Product Classification
INGREDIENTS (6)
SUMATRIPTAN SUCCINATEActive
Quantity: 25 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
sumatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3852
Application NumberNDA020132
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2012
FDA Product Classification
INGREDIENTS (6)
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT