Celecoxib

Product NDC
42708-016
11-digit product format
427080016
Labeler code
42708
Product ID
42708-016_bd5ab3f6-a8d0-1080-e053-2995a90abc4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
QPharma Inc
Application
ANDA076898
Marketing category
ANDA
Marketing start
2014-12-10
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42708-016DDiscontinued by firm2026-08-17
excluded packagepackage42708-01642708-016-30DDiscontinued 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 1 · 24 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 packagepackage42708-016-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42708-016-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42708-016-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42708-016-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42708-016-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42708-016-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42708-016-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42708-016-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42708-016-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42708-016-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42708-016-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42708-016-30557ba5c1ecfa…9c80585c8c6e…

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

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
A076898-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2014-05-30
A076898-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2014-05-30
A076898-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2014-05-30
A076898-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2014-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076898-001AB
A076898-002AB
A076898-003AB
A076898-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076898-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076898-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076898-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-004AB1d8e5a09893c0…

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-016-304270800163030 CAPSULE in 1 BOTTLE (42708-016-30) 30 capsule2018-03-140000-00-00YesNoCurrent