Celecoxib

Product NDC: 68084-976
11-digit product format: 680840976
Labeler code: 68084
Product ID: 68084-976_8d6dcbf8-d1c3-7026-e053-2a95a90a564d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076898
Marketing category: ANDA
Marketing start: 2015-02-03
Marketing end: 2021-01-31
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: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68084-976		D	Discontinued by firm	2026-10-12
excluded package	package	68084-976	68084-976-01	D	Discontinued by firm	2026-10-12
excluded package	package	68084-976	68084-976-32	D	Discontinued by firm	2026-10-12

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68084-976-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68084-976-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-976-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-976-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68084-976-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68084-976-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68084-976-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68084-976-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68084-976-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68084-976-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68084-976-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68084-976-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68084-976-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68084-976-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68084-976-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68084-976-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68084-976-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68084-976-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68084-976-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68084-976-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68084-976-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68084-976-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68084-976-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68084-976-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076898-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30
A076898-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30
A076898-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30
A076898-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30

Therapeutic equivalence codes#

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

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

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076898-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076898-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076898-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076898-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2014-05-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A076898-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076898-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076898-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076898-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076898-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076898-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076898-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076898-004	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076898-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076898-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076898-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076898-004	AB	1	`a50c72e98297…`

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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-976-01	EA - Each	68084-976	ea279450-3baa-42c3-a664-9b3a77d7b618	1	2015-12-02
68084-976-11	EA - Each	68084-976	f2d152d3-a6f6-415b-8880-96ef8f556e85	1	2015-12-02
68084-976-32	EA - Each	68084-976	6e4063c1-31b4-4a2e-a604-987a93020b58	1	2015-03-03
68084-976-33	EA - Each	68084-976	c99b302d-169e-4b8a-bf7b-4e247def2cbb	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]	2