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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-0145
Application NumberNDA018147
Product Classification
M
Marketing Category
C73605
G
Generic Name
piroxicam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-0140
Application NumberNDA018147
Product Classification
M
Marketing Category
C73605
G
Generic Name
piroxicam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2023
FDA Product Classification
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