Piroxicam
These highlights do not include all the information needed to use Piroxicam safely and effectively. See full prescribing information for Piroxicam. Piroxicam capsules, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
70be7d33-bc8b-4f48-84c6-a8e3d1476e97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2023
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
piroxicam
PRODUCT DETAILS
NDC Product Code59762-0145
Application NumberNDA018147
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 2, 2023
Generic Namepiroxicam
INGREDIENTS (7)
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
PIROXICAMActive
Quantity: 20 mg in 1 1
Code: 13T4O6VMAM
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
piroxicam
PRODUCT DETAILS
NDC Product Code59762-0140
Application NumberNDA018147
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 2, 2023
Generic Namepiroxicam
INGREDIENTS (7)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PIROXICAMActive
Quantity: 10 mg in 1 1
Code: 13T4O6VMAM
Classification: ACTIB
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT