Celecoxib

Product NDC
59746-562
11-digit product format
597460562
Labeler code
59746
Product ID
59746-562_c0ee4996-6a07-4e2e-aa45-54ebe2e5f5fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA207061
Marketing category
ANDA
Marketing start
2017-04-04
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 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
2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59746-562DDiscontinued by firm2026-08-03
excluded packagepackage59746-56259746-562-01DDiscontinued by firm2026-08-03
excluded packagepackage59746-56259746-562-05DDiscontinued by firm2026-08-03
excluded packagepackage59746-56259746-562-10DDiscontinued by firm2026-08-03
excluded packagepackage59746-56259746-562-30DDiscontinued by firm2026-08-03

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 · 75 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 packagepackage59746-562-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-562-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-562-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-562-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-562-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-562-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-562-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-562-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-562-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-562-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-562-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59746-562-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-562-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-562-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-562-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59746-562-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-562-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-562-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-562-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59746-562-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-562-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-562-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-562-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59746-562-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-562-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-562-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-562-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59746-562-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-562-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-562-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-562-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59746-562-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-562-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-562-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-562-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59746-562-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-562-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-562-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-562-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-562-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-562-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-562-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-562-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-562-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-562-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-562-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-562-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-562-30557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207061-001CELECOXIBCELECOXIB50MGCAPSULE / ORAL2017-04-04
A207061-002CELECOXIBCELECOXIB100MGCAPSULE / ORAL2017-04-04
A207061-003CELECOXIBCELECOXIB200MGCAPSULE / ORAL2017-04-04
A207061-004CELECOXIBCELECOXIB400MGCAPSULE / ORAL2017-04-04

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207061-001CELECOXIB50MGCAPSULE / ORAL2017-04-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A207061-002CELECOXIB100MGCAPSULE / ORAL2017-04-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A207061-003CELECOXIB200MGCAPSULE / ORAL2017-04-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A207061-004CELECOXIB400MGCAPSULE / ORAL2017-04-04d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A207061-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207061-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207061-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207061-004AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207061-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207061-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207061-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207061-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207061-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207061-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207061-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207061-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207061-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207061-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207061-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207061-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207061-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207061-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207061-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207061-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207061-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207061-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207061-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207061-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207061-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207061-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207061-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207061-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207061-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207061-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207061-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207061-004AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59746-562-012026-01-05These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-052026-01-05These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-102026-01-05These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-302026-01-05These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-012023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-052023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-102023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-302023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-562CELECOXIB (CELECOXIB) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]8Legacy NDC20210403_27d813ea-7798-09cb-734b-b970d7248f1f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-562-0159746056201100 CAPSULE in 1 BOTTLE (59746-562-01) 100 capsule2017-04-040000-00-00NoNoCurrent
59746-562-0559746056205500 CAPSULE in 1 BOTTLE (59746-562-05) 500 capsule2017-04-040000-00-00NoNoCurrent
59746-562-10597460562101000 CAPSULE in 1 BOTTLE (59746-562-10) 1000 capsule2017-04-040000-00-00NoNoCurrent
59746-562-305974605623030 CAPSULE in 1 BOTTLE (59746-562-30) 30 capsule2017-04-040000-00-00NoNoCurrent