Celecoxib

Product NDC: 60760-942
11-digit product format: 607600942
Labeler code: 60760
Product ID: 60760-942_59f495e8-3ce9-9d98-e063-6394a90a89d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA208856
Marketing category: ANDA
Marketing start: 2026-08-25
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
A208856-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07
A208856-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07
A208856-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07
A208856-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208856-001	AB
A208856-002	AB
A208856-003	AB
A208856-004	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 · 168 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	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-08-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A208856-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208856-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208856-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208856-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208856-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208856-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208856-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208856-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208856-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208856-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208856-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208856-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208856-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208856-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208856-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208856-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208856-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208856-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208856-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208856-004	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
59f495e8-3cea-9d98-e063-6394a90a89d4	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	St. Mary's Medical Park Pharmacy	59f495e8-3cea-9d98-e063-6394a90a89d4	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208856 application number: ANDA208856 ndc (product): 60760-942
Celecoxib	CELECOXIB	AiPing Pharmaceutical, Inc.	89db0dec-3800-4d89-a765-24838f4d0c30	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208856 application number: ANDA208856
CELECOXIB	CELECOXIB	Qingdao BAHEAL Pharmaceutical Co., Ltd.	87c16a33-5eb0-40b0-a020-ed924326f697	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208856 application number: ANDA208856

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
60760-942-60	60760094260	60 CAPSULE in 1 BOTTLE, PLASTIC (60760-942-60)	60 capsule	2026-08-25	No	No	Current