FDA.reportPublic FDA data

Piroxicam

Product NDC
52959-232
11-digit product format
529590232
Labeler code
52959
Product ID
52959-232_bd59acb2-4996-4167-a558-00c59a0653d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA074131
Marketing category
ANDA
Marketing start
2012-04-16
Marketing end
0000-00-00
Substance
PIROXICAM
Active strength
20 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0da159c-8d1d-04a0-3db4-d969b0f40913Product name920180912

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-232-002019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-072019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-092019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-102019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-142019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-152019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-182019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-202019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-212019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-302019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-602019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-232-902019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-232-30Therafeldamine30 in 1 BOTTLECAPSULE3020 mg8
52959-232-00Piroxicam100 in 1 BOTTLECAPSULE1002
52959-232-07Piroxicam7 in 1 BOTTLECAPSULE72
52959-232-09Piroxicam9 in 1 BOTTLECAPSULE92
52959-232-10Piroxicam10 in 1 BOTTLECAPSULE102
52959-232-14Piroxicam14 in 1 BOTTLECAPSULE142
52959-232-15Piroxicam15 in 1 BOTTLECAPSULE152
52959-232-18Piroxicam18 in 1 BOTTLECAPSULE182
52959-232-20Piroxicam20 in 1 BOTTLECAPSULE202
52959-232-21Piroxicam21 in 1 BOTTLECAPSULE212
52959-232-30Piroxicam30 in 1 BOTTLECAPSULE302
52959-232-60Piroxicam60 in 1 BOTTLECAPSULE602
52959-232-90Piroxicam90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-232-07EA - Each52959-232b9d76a07-7af6-46cb-a095-bac6bfdfcce712012-07-24
52959-232-09EA - Each52959-232b7add609-d09c-4d46-a6dc-53a8c13a843f12012-07-24
52959-232-10EA - Each52959-232d4ab909b-b25f-409a-888e-2f240f6a180712012-07-24
52959-232-14EA - Each52959-2322070f0fa-2c57-4a02-8763-3208f833c8c112012-07-24
52959-232-15EA - Each52959-232809edc68-7453-4b15-ae25-a57fca95e10712012-07-24
52959-232-18EA - Each52959-232a91e3e2b-23e4-4aa8-91a4-e81d582ac31112012-07-24
52959-232-20EA - Each52959-2322e78a63a-2519-43ff-b594-377b6b668adb12012-07-24
52959-232-21EA - Each52959-232fb08641d-1b9a-4362-9b1d-c6d3fa827e1112012-07-24
52959-232-30EA - Each52959-232a780a862-136d-46b8-baff-9312b035113612012-07-24
52959-232-60EA - Each52959-232b8ce0f14-dcc9-43ac-a975-97e28bf9181712012-07-24
52959-232-90EA - Each52959-232553e97d7-b3de-45e7-85ba-41ff29abe8a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
PIROXICAMACTIVE INGREDIENT13T4O6VMAMTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
PIROXICAMACTIVE MOIETY13T4O6VMAMTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
GELATININACTIVE INGREDIENT2G86QN327LTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
POVIDONEINACTIVE INGREDIENTFZ989GH94ETHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
PIROXICAMACTIVE INGREDIENT13T4O6VMAMPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
PIROXICAMACTIVE MOIETY13T4O6VMAMPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-232THERAFELDAMINE (PIROXICAM, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8Legacy NDC20110812_403af9f8-63bf-41a2-bf3b-20e5b92c389a.zip
52959-232PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 12 package rows20120430_4314317f-436e-4c70-b418-220a4c984727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198108piroxicam 20 MG Oral CapsulePSN403af9f8-63bf-41a2-bf3b-20e5b92c389a8
198108piroxicam 20 MG Oral CapsuleSCD403af9f8-63bf-41a2-bf3b-20e5b92c389a8
198107piroxicam 10 MG Oral CapsulePSN4314317f-436e-4c70-b418-220a4c9847272
198108piroxicam 20 MG Oral CapsulePSN4314317f-436e-4c70-b418-220a4c9847272
198107piroxicam 10 MG Oral CapsuleSCD4314317f-436e-4c70-b418-220a4c9847272
198108piroxicam 20 MG Oral CapsuleSCD4314317f-436e-4c70-b418-220a4c9847272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-232-0052959023200100 in 1 BOTTLEHistorical
52959-232-07529590232077 in 1 BOTTLEHistorical
52959-232-09529590232099 in 1 BOTTLEHistorical
52959-232-105295902321010 in 1 BOTTLEHistorical
52959-232-145295902321414 in 1 BOTTLEHistorical
52959-232-155295902321515 in 1 BOTTLEHistorical
52959-232-185295902321818 in 1 BOTTLEHistorical
52959-232-205295902322020 in 1 BOTTLEHistorical
52959-232-215295902322121 in 1 BOTTLEHistorical
52959-232-305295902323030 in 1 BOTTLEHistorical
52959-232-605295902326060 in 1 BOTTLEHistorical
52959-232-905295902329090 in 1 BOTTLEHistorical