SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateTablets
Approved
Approval ID
5388055e-ca76-4c80-b047-14eccb95ed24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2010
Manufacturers
FDA
Dispensing Solutions Inc.
DUNS: 066070785
Products 2
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 Code68258-3008
Application NumberNDA020132
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2010
FDA Product Classification
INGREDIENTS (6)
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
sumatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-3009
Application NumberNDA020132
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2010
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT