FDA.reportPublic FDA data

PIROXICAM

Product NDC
42571-176
11-digit product format
425710176
Labeler code
42571
Product ID
42571-176_50d3ac59-5397-4fc3-e063-6294a90a73e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA206152
Marketing category
ANDA
Marketing start
2018-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PIROXICAM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIROXICAM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii13T4O6VMAM
Rxcui198107, 198108

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-176-01PIROXICAM100 in 1 BOTTLECAPSULE10013
42571-176-05PIROXICAM500 in 1 BOTTLECAPSULE50013
42571-176-10PIROXICAM1000 in 1 BOTTLECAPSULE100013
42571-176-15PIROXICAM15 in 1 BOTTLECAPSULE1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-176-01EA - Each42571-176a59d1268-4a9e-41a1-9c3f-1a76e4b9b79012018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-176PIROXICAM (PIROXICAM) CAPSULE [MICRO LABS LIMITED]11Current NDC, Legacy NDC, 4 package rows20241128_a6335245-7e04-46b9-a505-f47647781e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198107piroxicam 10 MG Oral CapsulePSNa6335245-7e04-46b9-a505-f47647781e1913
198108piroxicam 20 MG Oral CapsulePSNa6335245-7e04-46b9-a505-f47647781e1913
198107piroxicam 10 MG Oral CapsuleSCDa6335245-7e04-46b9-a505-f47647781e1913
198108piroxicam 20 MG Oral CapsuleSCDa6335245-7e04-46b9-a505-f47647781e1913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-176-0142571017601100 CAPSULE in 1 BOTTLE (42571-176-01) 100 capsule2018-03-010000-00-00NoNoCurrent
42571-176-0542571017605500 CAPSULE in 1 BOTTLE (42571-176-05) 500 capsule2018-03-010000-00-00NoNoCurrent
42571-176-10425710176101000 CAPSULE in 1 BOTTLE (42571-176-10) 1000 capsule2018-03-010000-00-00NoNoCurrent
42571-176-154257101761515 CAPSULE in 1 BOTTLE (42571-176-15) 15 capsule2018-03-010000-00-00NoNoCurrent