sumatriptan succinate
These highlights do not include all the information needed to use SUMATRIPTAN SUCCINATE TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN SUCCINATE TABLETS . SUMATRIPTAN SUCCINATE tablets, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
f56c3681-bb45-429d-a266-90cd4cfbcec9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
Products 1
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 Code55700-846
Application NumberANDA078295
Product Classification
M
Marketing Category
C73584
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2020
FDA Product Classification
INGREDIENTS (12)
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT