FDA.reportPublic FDA data

PIROXICAM

Product NDC
42571-177
11-digit product format
425710177
Labeler code
42571
Product ID
42571-177_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
20 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
PIROXICAM20 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
42571-177-01PIROXICAM100 in 1 BOTTLECAPSULE10013
42571-177-05PIROXICAM500 in 1 BOTTLECAPSULE50013
42571-177-10PIROXICAM1000 in 1 BOTTLECAPSULE100013
42571-177-15PIROXICAM15 in 1 BOTTLECAPSULE1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-177-01EA - Each42571-177df4113b7-f1d2-4786-8b96-f72d1895a4f812018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-177PIROXICAM (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
198108piroxicam 20 MG Oral CapsulePSN8b8eb243-0efb-4777-b627-b7ae042f8823101
198108piroxicam 20 MG Oral CapsuleSCD8b8eb243-0efb-4777-b627-b7ae042f8823101
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
198108piroxicam 20 MG Oral CapsulePSNb48a1615-23b5-4db7-bb96-cec551d227f64
198108piroxicam 20 MG Oral CapsuleSCDb48a1615-23b5-4db7-bb96-cec551d227f64
198108piroxicam 20 MG Oral CapsulePSN7dbe6e12-3ab8-4d8a-8c1f-bbf4ae3d6c711
198108piroxicam 20 MG Oral CapsuleSCD7dbe6e12-3ab8-4d8a-8c1f-bbf4ae3d6c711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-177-0142571017701100 CAPSULE in 1 BOTTLE (42571-177-01) 100 capsule2018-03-010000-00-00NoNoCurrent
42571-177-0542571017705500 CAPSULE in 1 BOTTLE (42571-177-05) 500 capsule2018-03-010000-00-00NoNoCurrent
42571-177-10425710177101000 CAPSULE in 1 BOTTLE (42571-177-10) 1000 capsule2018-03-010000-00-00NoNoCurrent
42571-177-154257101771515 CAPSULE in 1 BOTTLE (42571-177-15) 15 capsule2018-03-010000-00-00NoNoCurrent