Home NDC 72189-350 Piroxicam
Product NDC 72189-350
11-digit product format 721890350
Labeler code 72189
Product ID 72189-350_2c4c7f43-5613-783e-e063-6294a90a578f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Piroxicam
Dosage form CAPSULE
Route ORAL
Labeler Direct_Rx
Application ANDA210347
Marketing category ANDA
Marketing start 2023-04-27
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-350-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-350-60 0efc9e666f02…f202fb6c5f17…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210347-001 PIROXICAM PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 A210347-002 PIROXICAM PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210347-001 PIROXICAM 10MG CAPSULE / ORAL AB 2018-01-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210347-002 PIROXICAM 20MG CAPSULE / ORAL AB 2018-01-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Piroxicam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIROXICAM 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 13T4O6VMAM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198108 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72189-350-60 Piroxicam 60 in 1 BOTTLE CAPSULE 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-350 PIROXICAM CAPSULE [DIRECT_RX] 2 Current NDC, 1 package rows 20250123_fa56b439-893d-003e-e053-6294a90a865b.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Piroxicam PIROXICAM PD-Rx Pharmaceuticals, Inc. 923a81d7-78e7-48e9-901d-e3ce3539aba3 2026-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210347 application number: ANDA210347 Piroxicam PIROXICAM AvKARE 1ea6042e-0090-df18-e063-6394a90a0a0a 2026-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210347 application number: ANDA210347 Piroxicam PIROXICAM Strides Pharma Science Limited 6039e036-c0aa-4249-af50-115f49ad758a 2025-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210347 application number: ANDA210347 Piroxicam PIROXICAM Direct_Rx fa56b439-893d-003e-e053-6294a90a865b 2025-01-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210347 application number: ANDA210347 ndc (product): 72189-350 Piroxicam PIROXICAM Bryant Ranch Prepack 7f5ea9e8-3942-4e84-b237-c38517a97a8e 2023-10-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210347 application number: ANDA210347
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72189-350-60 72189035060 60 CAPSULE in 1 BOTTLE (72189-350-60) 60 capsule 2023-04-27 No No Current