FDA.reportPublic FDA data

Piroxicam

Product NDC
64380-843
11-digit product format
643800843
Labeler code
64380
Product ID
64380-843_8eece898-b653-42a6-a7e5-4aeaa562b4dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA210347
Marketing category
ANDA
Marketing start
2018-05-07
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
2026-12-31
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
64380-843-06Piroxicam100 in 1 BOTTLECAPSULE1009
64380-843-07Piroxicam500 in 1 BOTTLECAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-843-06EA - Each64380-843f254cd5e-4f81-4ada-b9f9-762e6572a61d12018-05-09
64380-843-07EA - Each64380-843b844f22f-b198-4d7c-b65c-0a2380388e7c12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-843PIROXICAM CAPSULE [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 2 package rows20250131_6039e036-c0aa-4249-af50-115f49ad758a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198108piroxicam 20 MG Oral CapsulePSN7f5ea9e8-3942-4e84-b237-c38517a97a8e103
198108piroxicam 20 MG Oral CapsuleSCD7f5ea9e8-3942-4e84-b237-c38517a97a8e103
198107piroxicam 10 MG Oral CapsulePSN923a81d7-78e7-48e9-901d-e3ce3539aba311
198108piroxicam 20 MG Oral CapsulePSN923a81d7-78e7-48e9-901d-e3ce3539aba311
198107piroxicam 10 MG Oral CapsuleSCD923a81d7-78e7-48e9-901d-e3ce3539aba311
198108piroxicam 20 MG Oral CapsuleSCD923a81d7-78e7-48e9-901d-e3ce3539aba311
198107piroxicam 10 MG Oral CapsulePSN6039e036-c0aa-4249-af50-115f49ad758a9
198108piroxicam 20 MG Oral CapsulePSN6039e036-c0aa-4249-af50-115f49ad758a9
198107piroxicam 10 MG Oral CapsuleSCD6039e036-c0aa-4249-af50-115f49ad758a9
198108piroxicam 20 MG Oral CapsuleSCD6039e036-c0aa-4249-af50-115f49ad758a9
198107piroxicam 10 MG Oral CapsulePSN1ea6042e-0090-df18-e063-6394a90a0a0a2
198108piroxicam 20 MG Oral CapsulePSN1ea6042e-0090-df18-e063-6394a90a0a0a2
198108piroxicam 20 MG Oral CapsulePSNfa56b439-893d-003e-e053-6294a90a865b2
198107piroxicam 10 MG Oral CapsuleSCD1ea6042e-0090-df18-e063-6394a90a0a0a2
198108piroxicam 20 MG Oral CapsuleSCD1ea6042e-0090-df18-e063-6394a90a0a0a2
198108piroxicam 20 MG Oral CapsuleSCDfa56b439-893d-003e-e053-6294a90a865b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-843-0664380084306100 CAPSULE in 1 BOTTLE (64380-843-06) 100 capsule2018-05-070000-00-00NoNoCurrent
64380-843-0764380084307500 CAPSULE in 1 BOTTLE (64380-843-07) 500 capsule2018-05-090000-00-00NoNoCurrent