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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206152-001PIROXICAMPIROXICAM10MGCAPSULE / ORALAB2017-12-29
A206152-002PIROXICAMPIROXICAM20MGCAPSULE / ORALAB2017-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206152-001AB
A206152-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206152-001PIROXICAM10MGCAPSULE / ORALAB2017-12-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A206152-002PIROXICAM20MGCAPSULE / ORALAB2017-12-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206152-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206152-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206152-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206152-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206152-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206152-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206152-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206152-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206152-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206152-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206152-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206152-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206152-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206152-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206152-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206152-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206152-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206152-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206152-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206152-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206152-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206152-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206152-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206152-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206152-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206152-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206152-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206152-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206152-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206152-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206152-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206152-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206152-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206152-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206152-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206152-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206152-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206152-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206152-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206152-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13T4O6VMAMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198107Internal RxNorm lookup
198108Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6335245-7e04-46b9-a505-f47647781e19Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIROXICAMPIROXICAMBryant Ranch Prepack8b8eb243-0efb-4777-b627-b7ae042f88232026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206152
application number: ANDA206152
PIROXICAMPIROXICAMMicro Labs Limiteda6335245-7e04-46b9-a505-f47647781e192026-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206152
application number: ANDA206152
ndc (product): 42571-177
PIROXICAMPIROXICAMProficient Rx LPb48a1615-23b5-4db7-bb96-cec551d227f62022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206152
application number: ANDA206152

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