Piroxicam

Product NDC
68382-742
11-digit product format
683820742
Labeler code
68382
Product ID
68382-742_4bc8e1b6-586d-4074-89f9-7183827dcc8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA205585
Marketing category
ANDA
Marketing start
2019-01-10
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-742DDiscontinued by firm2026-08-17
excluded packagepackage68382-74268382-742-01DDiscontinued by firm2026-08-17
excluded packagepackage68382-74268382-742-05DDiscontinued by firm2026-08-17
excluded packagepackage68382-74268382-742-06DDiscontinued by firm2026-08-17
excluded packagepackage68382-74268382-742-10DDiscontinued by firm2026-08-17
excluded packagepackage68382-74268382-742-16DDiscontinued by firm2026-08-17
excluded packagepackage68382-74268382-742-77DDiscontinued by firm2026-08-17

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 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-742-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-742-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-742-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-742-77d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-742-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-742-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-742-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-742-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-742-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-742-77f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-742-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-742-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-742-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-742-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-742-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-742-772ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-742-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-742-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-742-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-742-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-742-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-742-77a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-742-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-742-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-742-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-742-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-742-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-742-77cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-742-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-742-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-742-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-742-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-742-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-742-77cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-742-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-742-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-742-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-742-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-742-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-742-77302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-742-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-742-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-742-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-742-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-742-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-742-77ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-742-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-742-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-742-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-742-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-742-100efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205585-001PIROXICAMPIROXICAM10MGCAPSULE / ORALAB2018-07-17
A205585-002PIROXICAMPIROXICAM20MGCAPSULE / ORALAB2018-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205585-001AB
A205585-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17caaa826d4ba7…
2026-08-18 06:07:402026-07A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205585-001PIROXICAM10MGCAPSULE / ORALAB2018-07-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205585-002PIROXICAM20MGCAPSULE / ORALAB2018-07-17bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205585-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205585-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205585-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205585-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205585-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205585-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205585-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205585-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205585-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205585-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205585-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205585-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205585-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205585-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205585-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205585-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205585-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205585-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205585-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205585-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205585-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205585-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205585-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205585-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205585-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205585-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205585-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205585-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205585-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205585-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205585-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205585-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205585-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205585-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205585-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205585-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205585-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205585-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205585-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205585-002AB1bb7c543d1eb4…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-742-0168382074201100 CAPSULE in 1 BOTTLE (68382-742-01) 100 capsule2019-01-100000-00-00NoNoCurrent
68382-742-0568382074205500 CAPSULE in 1 BOTTLE (68382-742-05) 500 capsule2019-01-100000-00-00NoNoCurrent
68382-742-066838207420630 CAPSULE in 1 BOTTLE (68382-742-06) 30 capsule2019-01-100000-00-00NoNoCurrent
68382-742-10683820742101000 CAPSULE in 1 BOTTLE (68382-742-10) 1000 capsule2019-01-100000-00-00NoNoCurrent
68382-742-166838207421690 CAPSULE in 1 BOTTLE (68382-742-16) 90 capsule2019-01-100000-00-00NoNoCurrent
68382-742-776838207427710 BLISTER PACK in 1 CARTON (68382-742-77) > 10 CAPSULE in 1 BLISTER PACK (68382-742-30) 10 blister pack2019-01-100000-00-00NoNoCurrent