ARTHROTEC
ARTHROTEC (diclofenac sodium/misoprostol) Tablets
Approved
Approval ID
4f0a7109-2915-4daa-a752-8f78cf040b37
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4164
Application NumberNDA020607
Product Classification
M
Marketing Category
C73594
G
Generic Name
diclofenac sodium and misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2012
FDA Product Classification
INGREDIENTS (14)
diclofenac sodiumActive
Quantity: 50 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
hydrogenated castor oilInactive
Code: ZF94AP8MEY
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
povidone K30Inactive
Code: U725QWY32X
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
diclofenac sodium and misoprostol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4165
Application NumberNDA020607
Product Classification
M
Marketing Category
C73594
G
Generic Name
diclofenac sodium and misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2012
FDA Product Classification
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
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
povidone K30Inactive
Code: U725QWY32X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
hydrogenated castor oilInactive
Code: ZF94AP8MEY
Classification: IACT