Celecoxib

Product NDC: 55154-0160
11-digit product format: 551540160
Labeler code: 55154
Product ID: 55154-0160_a9114d6a-13d7-443c-be44-7866b4a4cf96
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA204519
Marketing category: ANDA
Marketing start: 2026-07-10
Substance: CELECOXIB
Active strength: 100 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A204519-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21
A204519-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21
A204519-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21
A204519-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204519-001	AB
A204519-002	AB
A204519-003	AB
A204519-004	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	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204519-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204519-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204519-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204519-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204519-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JCX84Q7J1L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205322	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a9114d6a-13d7-443c-be44-7866b4a4cf96	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Major Pharmaceuticals	3a1eadd5-c0a7-473e-bde0-6b9450d11c95	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Alembic Pharmaceuticals Inc.	806e5f8a-f986-4f88-ba3e-8265f86afa48	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Cardinal Health 107, LLC	a9114d6a-13d7-443c-be44-7866b4a4cf96	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519 ndc (product): 55154-0160
Celecoxib	CELECOXIB	AvPAK	951df0f7-5fb7-40f5-e053-2995a90a1edd	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	RedPharm Drug	2fbaa580-f33a-417d-e063-6294a90ad7df	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Alembic Pharmaceuticals Limited	14e8d788-e44c-4a40-8678-25cf45fed477	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib 200 mg	CELECOXIB	Proficient Rx LP	feee6a01-63f9-42c3-8bd8-ca713a08b36d	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Proficient Rx LP	7a234c0c-30a7-49f5-92a1-a1fc836ff9ae	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Proficient Rx LP	c787b0ab-77ab-4f7e-9fea-be2a0085020a	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JCX84Q7J1L	CELECOXIB	169590-42-5	CELECOXIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-0160-0	55154016000	10 BLISTER PACK in 1 BAG (55154-0160-0) / 1 CAPSULE in 1 BLISTER PACK	10 blister pack	2026-07-10	No	No	Current