FDA.reportPublic FDA data

Piroxicam

Product NDC
29033-012
11-digit product format
290330012
Labeler code
29033
Product ID
29033-012_7a032585-1f84-4c4b-a1a7-0088f1d53e8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Nostrum Laboratories, Inc.
Application
ANDA074116
Marketing category
ANDA
Marketing start
2020-02-20
Marketing end
0000-00-00
Substance
PIROXICAM
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
29033-012-012026-01-29C16284748780-149896155-a300-586f-e063-e6dba90add90These highlights do not include all the information needed to use PIROXICAM CAPSULES safely and effectively. See full prescribing information for PIROXICAM CAPSULES. PIROXICAM capsules, for oral use Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29033-012-01Piroxicam100 in 1 BOTTLE, PLASTICCAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29033-012-01EA - Each29033-012eea94e27-6830-4571-80a5-20b8a64fad3a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
piroxicamACTIVE INGREDIENT13T4O6VMAMPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
piroxicamACTIVE MOIETY13T4O6VMAMPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
GELATININACTIVE INGREDIENT2G86QN327LPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]7
piroxicamACTIVE INGREDIENT13T4O6VMAMPIROXICAM CAPSULE [REBEL DISTRIBUTORS CORP]1
PiroxicamACTIVE MOIETY13T4O6VMAMPIROXICAM CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29033-012PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]9Legacy NDC, 1 package rows20200220_1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198107piroxicam 10 MG Oral CapsulePSN7ee820e4-a479-4b7d-8730-101ac1f8015c102
198107piroxicam 10 MG Oral CapsuleSCD7ee820e4-a479-4b7d-8730-101ac1f8015c102
198107piroxicam 10 MG Oral CapsulePSNd9684cb2-76f3-4c1b-b9e5-1f8fe55f3695100
198107piroxicam 10 MG Oral CapsuleSCDd9684cb2-76f3-4c1b-b9e5-1f8fe55f3695100
198107piroxicam 10 MG Oral CapsulePSN1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e9
198108piroxicam 20 MG Oral CapsulePSN1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e9
198107piroxicam 10 MG Oral CapsuleSCD1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e9
198108piroxicam 20 MG Oral CapsuleSCD1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e9
198107piroxicam 10 MG Oral CapsulePSN53b33c73-a220-4add-ba61-b00e9e9f852b1
198108piroxicam 20 MG Oral CapsulePSN53b33c73-a220-4add-ba61-b00e9e9f852b1
198107piroxicam 10 MG Oral CapsuleSCD53b33c73-a220-4add-ba61-b00e9e9f852b1
198108piroxicam 20 MG Oral CapsuleSCD53b33c73-a220-4add-ba61-b00e9e9f852b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29033-012-0129033001201100 CAPSULE in 1 BOTTLE, PLASTIC (29033-012-01) 100 capsule2020-02-200000-00-00NoNoCurrent