Piroxicam

Product NDC
67544-807
11-digit product format
675440807
Labeler code
67544
Product ID
67544-807_b6848545-e2e1-40d1-aa7e-e5f6100b9edd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074131
Marketing category
ANDA
Marketing start
1994-01-26
Marketing end
0000-00-00
Substance
PIROXICAM
Active strength
20 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
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-807-20Piroxicam20 in 1 BOTTLE, PLASTICCAPSULE201
67544-807-30Piroxicam30 in 1 BOTTLE, PLASTICCAPSULE301
67544-807-60Piroxicam90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-807-60EA - Each67544-80799f6af72-a977-4449-9569-981803cdf48212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIROXICAMACTIVE INGREDIENT13T4O6VMAMPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PIROXICAMACTIVE MOIETY13T4O6VMAMPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-807PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20140507_0c12b60f-ec25-4c59-8b2e-4445e600d051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198108piroxicam 20 MG Oral CapsulePSN0c12b60f-ec25-4c59-8b2e-4445e600d0511
198108piroxicam 20 MG Oral CapsuleSCD0c12b60f-ec25-4c59-8b2e-4445e600d0511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-807-206754408072020 in 1 BOTTLE, PLASTICHistorical
67544-807-306754408073030 in 1 BOTTLE, PLASTICHistorical
67544-807-606754408076090 in 1 BOTTLE, PLASTICHistorical