Home NDC 42543-114 Piroxicam
Product NDC 42543-114
11-digit product format 425430114
Labeler code 42543
Product ID 42543-114_bceebd41-54dd-4a1e-b250-f1e460bb903d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Piroxicam
Dosage form CAPSULE
Route ORAL
Labeler Vensun Pharmaceuticals, Inc.
Application ANDA206136
Marketing category ANDA
Marketing start 2017-09-28
Marketing end 0000-00-00
Substance PIROXICAM
Active strength 10 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42543-114-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42543-114-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42543-114-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42543-114-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42543-114-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42543-114-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42543-114-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42543-114-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42543-114-01 U Excluded because listing certification expired 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 A206136-001 PIROXICAM PIROXICAM 10MG CAPSULE / ORAL 2017-06-20 A206136-002 PIROXICAM PIROXICAM 20MG CAPSULE / ORAL 2017-06-20
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 A206136-001 PIROXICAM 10MG CAPSULE / ORAL 2017-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206136-002 PIROXICAM 20MG CAPSULE / ORAL 2017-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206136-001 PIROXICAM 10MG CAPSULE / ORAL AB 2017-06-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206136-002 PIROXICAM 20MG CAPSULE / ORAL AB 2017-06-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42543-114-01 Piroxicam 100 in 1 BOTTLE, PLASTIC CAPSULE 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42543-114 PIROXICAM CAPSULE [VENSUN PHARMACEUTICALS, INC.] 8 Legacy NDC, 1 package rows 20190702_18120467-c024-4d5a-8fcf-105e72a3e671.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Piroxicam PIROXICAM Proficient Rx LP 23972bf0-e5b8-4f4b-97d0-caa05d6b061c 2019-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206136 application number: ANDA206136
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42543-114-01 42543011401 100 CAPSULE in 1 BOTTLE, PLASTIC (42543-114-01) 100 capsule 2017-09-28 0000-00-00 No No Current