ARTHROTEC
ARTHROTEC (diclofenac sodium/misoprostol) Tablets
Approved
Approval ID
1cdede45-4e2b-490a-bd22-eca5315af316
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2009
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.
diclofenac sodium and misoprostol
PRODUCT DETAILS
NDC Product Code21695-425
Application NumberNDA020607
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 10, 2009
Generic Namediclofenac sodium and misoprostol
INGREDIENTS (14)
diclofenac sodiumActive
Quantity: 75 mg in 1 1
Code: QTG126297Q
Classification: ACTIB
misoprostolActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
povidone K30Inactive
Code: U725QWY32X
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
hydrogenated castor oilInactive
Code: ZF94AP8MEY
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT