Piroxicam
These highlights do not include all the information needed to use PIROXICAM CAPSULES USP safely and effectively. See full prescribing information for PIROXICAM CAPSULES USP PIROXICAM CAPSULES USP, for oral useInitial U.S. Approval: 1982
Approved
Approval ID
8f9301ad-25ed-4090-ab71-378fe3d72eda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2022
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
Products 1
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 Code55700-697
Application NumberANDA210347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piroxicam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2018
FDA Product Classification
INGREDIENTS (11)
PIROXICAMActive
Quantity: 20 mg in 1 1
Code: 13T4O6VMAM
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT