Celecoxib

Product NDC: 60760-649
11-digit product format: 607600649
Labeler code: 60760
Product ID: 60760-649_51025b88-f1d1-880d-e063-6394a90a02c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA205129
Marketing category: ANDA
Marketing start: 2022-10-25
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60760-649	60760-649-30	D	Discontinued by firm		2026-10-05

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
A205129-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03
A205129-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03
A205129-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03
A205129-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205129-001	AB
A205129-002	AB
A205129-003	AB
A205129-004	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 4 · 152 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	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 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	A205129-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205129-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205129-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205129-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-004	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
ed2093f6-1606-100a-e053-2995a90a5b95	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9a	Product name	1	20200925
827beb42-45f2-95b8-6aa3-f35174375422	Product name	9	20160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60760-649-30	Celecoxib	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		3
60760-649-60	Celecoxib	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-649-30	EA - Each	60760-649	71fefad8-aecf-4d21-999b-69a1e0ea7ccf	1	2023-09-05
60760-649-60	EA - Each	60760-649	4187eb91-979f-4b5f-8da5-75f67ca94a23	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-649	CELECOXIB CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]	2	Current NDC, Legacy NDC, 2 package rows	20230516_ed2093f6-1606-100a-e053-2995a90a5b95.zip

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Medsource Pharmaceuticals	14962aef-7609-b29a-e063-6394a90a5399	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Bryant Ranch Prepack	631154cd-8f61-41b2-a686-80edc711cdaa	2024-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Proficient Rx LP	b9a7f32c-8136-4f29-be6b-4d5e904ca0f1	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Aphena Pharma Solutions - Tennessee, LLC	d258e065-e9a6-44e2-89c9-6892d771d9d3	2021-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205322	celecoxib 100 MG Oral Capsule	PSN	ed2093f6-1606-100a-e053-2995a90a5b95	3
205322	celecoxib 100 MG Oral Capsule	SCD	ed2093f6-1606-100a-e053-2995a90a5b95	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-649-30	60760064930	30 in 1 BOTTLE, PLASTIC						Historical
60760-649-60	60760064960	60 CAPSULE in 1 BOTTLE, PLASTIC (60760-649-60)	60 capsule	2022-10-25	0000-00-00	No	No	Current