celecoxib

Product NDC: 60760-824
11-digit product format: 607600824
Labeler code: 60760
Product ID: 60760-824_7a03243a-df17-8a1c-e053-2991aa0a9f35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA204590
Marketing category: ANDA
Marketing start: 2018-07-30
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: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60760-824		D	Discontinued by firm	2026-08-17
excluded package	package	60760-824	60760-824-15	D	Discontinued by firm	2026-08-17
excluded package	package	60760-824	60760-824-30	D	Discontinued by firm	2026-08-17
excluded package	package	60760-824	60760-824-60	D	Discontinued by firm	2026-08-17

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204590-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16
A204590-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16
A204590-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16
A204590-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204590-001	AB
A204590-002	AB
A204590-003	AB
A204590-004	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
2026-08-18 06:07:40	2026-07	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`d8e5a09893c0…`

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
2026-08-18 06:07:40	2026-07	A204590-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204590-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204590-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-004	AB	1	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-824-15	EA - Each	60760-824	aa2aa803-8547-4723-81b1-fe9dd04fbeae	1	2018-10-11
60760-824-30	EA - Each	60760-824	43185b96-efc3-49c3-9080-afe1465aac91	1	2018-11-06
60760-824-60	EA - Each	60760-824	b3854549-8e0d-4882-99af-1467d3513aaa	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-824	CELECOXIB CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]	4	Legacy NDC	20181107_723b16bd-274d-a29e-e053-2991aa0abd63.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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
celecoxib	CELECOXIB	HAWAII REPACK, INC.	45816eae-ad83-4d2f-a035-c3f9f24708f9	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	78d59905-4a78-4d9f-ac29-58790a5b3a92	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Macleods Pharmaceuticals Limited	d14aecf5-16e9-459a-bda4-4ca8f290796a	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Preferred Pharmaceuticals Inc.	a6000132-ac6c-4b61-a98a-8cc2dd84b3f0	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Preferred Pharmaceuticals, Inc.	2fc74af6-4573-411d-9082-f3edd44a52a4	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
CELECOXIB	CELECOXIB	Direct Rx	ac87b4f9-3f66-8cf7-e053-2995a90ade0f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Sportpharm LLC	1ae11faa-5bbe-49b7-a4dd-b573c304cf66	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Northwind Health Company, LLC	c213e224-c2fb-726e-e053-2a95a90a21c5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Bryant Ranch Prepack	351f5f07-bdd4-9893-e063-6394a90a7281	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	RedPharm Drug, Inc.	50c29846-3426-0310-e054-00144ff8d46c	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Asclemed USA, Inc.	f6291230-7598-407a-aef0-ec1f09277d2a	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Bryant Ranch Prepack	ac5c0d72-1bb3-4065-b2f4-5516b0869775	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af73fea0-5cd1-0fa2-e053-2a95a90af8fc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	b3545cfb-97c3-b896-e053-2a95a90a15a0	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c8ade384-2072-2cc2-e053-2a95a90ae791	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f8fdd580-09da-9c1c-e053-6394a90a4706	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Quality Care Products LLC	f0df546e-17c9-4e85-839d-336612d7b9e5	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	NuCare Pharmaceuticals,Inc.	69aebbab-9906-be86-e053-2991aa0aa8a5	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Asclemed USA, Inc.	2a926010-08e1-44dd-bc6d-ed15374bd0d3	2023-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Proficient Rx LP	0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d0	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590

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	Marketing end	Sample	Exclude flag	Status
60760-824-15	60760082415	15 CAPSULE in 1 BOTTLE, PLASTIC (60760-824-15)	15 capsule	2018-07-30	0000-00-00	No	No	Current
60760-824-30	60760082430	30 CAPSULE in 1 BOTTLE, PLASTIC (60760-824-30)	30 capsule	2018-09-18	0000-00-00	No	No	Current
60760-824-60	60760082460	60 CAPSULE in 1 BOTTLE, PLASTIC (60760-824-60)	60 capsule	2018-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
celecoxib	St. Mary's Medical Park Pharmacy \| Macleods Pharmaceuticals Limited	2018-11-06	HUMAN PRESCRIPTION DRUG LABEL	4