FDA.reportPublic FDA data

Piroxicam

Product NDC
42291-674
11-digit product format
422910674
Labeler code
42291
Product ID
42291-674_ec18f190-bda4-6d26-e053-2995a90a2d66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA074131
Marketing category
ANDA
Marketing start
2013-06-27
Marketing end
0000-00-00
Substance
PIROXICAM
Active strength
10 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-674-01EA - Each42291-6749b4c7e7e-669c-4f3a-b6e9-280582b227f212013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIROXICAMACTIVE INGREDIENT13T4O6VMAMPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
PIROXICAMACTIVE MOIETY13T4O6VMAMPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-674PIROXICAM CAPSULE [AVKARE]11Legacy NDC20240111_3fa3d666-3154-23a7-1c69-915cd6f6a87c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-674-0142291067401100 CAPSULE in 1 BOTTLE (42291-674-01) 100 capsule2013-06-270000-00-00NoNoCurrent