TREXIMET
TREXIMET (sumatriptan and naproxen sodium)Tablets
Approved
Approval ID
e08d5f22-f9c3-4627-8e5a-72c95183cf6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sumatriptan succinate and naproxen sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-954
Application NumberNDA021926
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate and naproxen sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2008
FDA Product Classification
INGREDIENTS (15)
SUMATRIPTAN SUCCINATEActive
Quantity: 85 mg in 1 1
Code: J8BDZ68989
Classification: ACTIB
NAPROXEN SODIUMActive
Quantity: 500 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT