Piroxicam
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1982
Approved
Approval ID
3fa3d666-3154-23a7-1c69-915cd6f6a87c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-674
Application NumberANDA074131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piroxicam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (20)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PIROXICAMActive
Quantity: 10 mg in 1 1
Code: 13T4O6VMAM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: IDK7C2HS09
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Piroxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-677
Application NumberANDA074131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piroxicam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (17)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: IDK7C2HS09
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PIROXICAMActive
Quantity: 20 mg in 1 1
Code: 13T4O6VMAM
Classification: ACTIB