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
18120467-c024-4d5a-8fcf-105e72a3e671
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2019
Manufacturers
FDA
Vensun Pharmaceuticals, Inc.
DUNS: 078310501
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 Code42543-114
Application NumberANDA206136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piroxicam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2018
FDA Product Classification
INGREDIENTS (9)
PiroxicamActive
Quantity: 10 mg in 1 1
Code: 13T4O6VMAM
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Piroxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-115
Application NumberANDA206136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piroxicam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2018
FDA Product Classification
INGREDIENTS (9)
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
PiroxicamActive
Quantity: 20 mg in 1 1
Code: 13T4O6VMAM
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT