Celecoxib

Product NDC
43353-257
11-digit product format
433530257
Labeler code
43353
Product ID
43353-257_e3381eee-5310-4f22-ae15-a059905f2c83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078857
Marketing category
ANDA
Marketing start
2015-11-09
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
200 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-257DDiscontinued by firm2026-10-16
excluded packagepackage43353-25743353-257-30DDiscontinued by firm2026-10-16
excluded packagepackage43353-25743353-257-53DDiscontinued by firm2026-10-16
excluded packagepackage43353-25743353-257-60DDiscontinued by firm2026-10-16

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 · 8 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 packagepackage43353-257-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-257-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-257-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-257-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-257-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-257-53f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078857-001CELECOXIBCELECOXIB50MGCAPSULE / ORAL2014-05-30
A078857-002CELECOXIBCELECOXIB100MGCAPSULE / ORAL2015-02-11
A078857-003CELECOXIBCELECOXIB200MGCAPSULE / ORAL2015-02-11
A078857-004CELECOXIBCELECOXIB400MGCAPSULE / ORAL2015-02-11

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-30c2088c7a36db…
2026-10-15 13:18:302026-09A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-11c2088c7a36db…
2026-10-15 13:18:302026-09A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-11c2088c7a36db…
2026-10-15 13:18:302026-09A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-11c2088c7a36db…
2026-09-14 22:38:342026-08A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-3084e616aacf4f…
2026-09-14 22:38:342026-08A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-1184e616aacf4f…
2026-08-18 06:07:402026-07A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078857-001CELECOXIB50MGCAPSULE / ORAL2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078857-002CELECOXIB100MGCAPSULE / ORAL2015-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078857-003CELECOXIB200MGCAPSULE / ORAL2015-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078857-004CELECOXIB400MGCAPSULE / ORAL2015-02-112680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-14 00:12 UTC2019-12A078857-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078857-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078857-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078857-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078857-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078857-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078857-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078857-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078857-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078857-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078857-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078857-004AB1ea99ee380514…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078857-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078857-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078857-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078857-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A078857-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A078857-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078857-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078857-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078857-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078857-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078857-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078857-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078857-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078857-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078857-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078857-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078857-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078857-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078857-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A078857-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A078857-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A078857-004AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078857-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078857-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078857-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078857-004AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-257-30EA - Each43353-257cf295bd0-9869-43e1-88cc-26900a88548b12017-10-13
43353-257-53EA - Each43353-25739f9fc03-d645-4de4-a8b1-7a592232237d12017-10-13
43353-257-60EA - Each43353-257d41bc4ef-0dfd-4326-878c-ee85a7e60a3612017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-257CELECOXIB CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171003_c5f4c4bf-f665-4b07-825a-51cc0ffb1788.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-257-304335302573030 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-30) 30 capsule2016-11-150000-00-00NoNoCurrent
43353-257-534335302575360 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-53) 60 capsule2017-06-130000-00-00NoNoCurrent
43353-257-604335302576090 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-60) 90 capsule2017-06-130000-00-00NoNoCurrent