FDA.reportPublic FDA data

Piroxicam

Product NDC
52959-398
11-digit product format
529590398
Labeler code
52959
Product ID
52959-398_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
10 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
52959-398-002019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-398-102019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-398-202019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-398-212019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-398-302019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only
52959-398-602019-11-13C16284748780-197449f38-b58b-f6ea-e053-dbdaa90aa703PIROXICAM CAPSULES USP 0756 0757 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-398-00Piroxicam100 in 1 BOTTLECAPSULE1002
52959-398-10Piroxicam10 in 1 BOTTLECAPSULE102
52959-398-20Piroxicam20 in 1 BOTTLECAPSULE202
52959-398-21Piroxicam21 in 1 BOTTLECAPSULE212
52959-398-30Piroxicam30 in 1 BOTTLECAPSULE302
52959-398-60Piroxicam60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-398-00EA - Each52959-398bbc61633-f9c5-4456-8561-9a8840738eaa12012-07-24
52959-398-10EA - Each52959-398c707a732-b007-47b7-91bf-21e1b2bfcd6b12012-07-24
52959-398-20EA - Each52959-398e8214142-1880-4a67-bc42-99ca27432f4012012-07-24
52959-398-21EA - Each52959-3980f5193f8-bf5f-45b1-b69b-c93c2f92324912012-07-24
52959-398-30EA - Each52959-3980af28344-2a7e-4db1-bf29-eb88037cb45512012-07-24
52959-398-60EA - Each52959-3980a4cfcce-9902-4348-865d-57742f033fa712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
52959-398PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 6 package rows20120430_4314317f-436e-4c70-b418-220a4c984727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
52959-398-0052959039800100 in 1 BOTTLEHistorical
52959-398-105295903981010 in 1 BOTTLEHistorical
52959-398-205295903982020 in 1 BOTTLEHistorical
52959-398-215295903982121 in 1 BOTTLEHistorical
52959-398-305295903983030 in 1 BOTTLEHistorical
52959-398-605295903986060 in 1 BOTTLEHistorical