Celecoxib

Product NDC: 50090-5178
Requested package NDC: 50090-5178-2
11-digit product format: 500905178
Labeler code: 50090
Product ID: 50090-5178_837139a9-a3a8-4a4f-b185-eb8dfacd68ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA204197
Marketing category: ANDA
Marketing start: 2015-06-03
Marketing end: 2027-01-31
Substance: CELECOXIB
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
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	50090-5178	50090-5178-2	D	Discontinued by firm		2026-08-17

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 · 11 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204197-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02
A204197-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02
A204197-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204197-001	AB
A204197-002	AB
A204197-003	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 · 126 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	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A204197-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204197-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204197-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	200 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
205323	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
217265c0-e98e-482c-8af2-f8ac0ab7a0a1	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5178-0	2023-02-07	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5178-1	2023-02-07	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5178-2	2023-02-07	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5178-0	2023-01-30	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5178-1	2023-01-30	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5178-2	2023-01-30	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-5178-0	Celecoxib	30 in 1 BOTTLE	CAPSULE	30	7
50090-5178-1	Celecoxib	60 in 1 BOTTLE	CAPSULE	60	7
50090-5178-2	Celecoxib	90 in 1 BOTTLE	CAPSULE	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5178-0	EA - Each	50090-5178	720f5f92-053e-4a3f-bcad-87123b852c59	1	2023-02-06
50090-5178-1	EA - Each	50090-5178	98265c05-3ce7-4085-8c3b-21cde0ad106f	1	2023-02-06
50090-5178-2	EA - Each	50090-5178	69d26c9f-7f31-46eb-a2cd-7240686d4762	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5178	CELECOXIB CAPSULE [A-S MEDICATION SOLUTIONS]	7	Current NDC, Legacy NDC, 3 package rows	20240919_217265c0-e98e-482c-8af2-f8ac0ab7a0a1.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Bryant Ranch Prepack	d94849a7-1831-4319-982c-c6b20dc42038	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	52572bfb-43f0-4b55-b1fd-231a05c8b83e	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197
Celecoxib	CELECOXIB	Apotex Corp.	a62612b3-9564-2b34-be59-6aa5ac53679c	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197
Celecoxib	CELECOXIB	A-S Medication Solutions	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197 ndc (package): 50090-5178-2 ndc (product): 50090-5178 ndc11 (package): 50090517802
Celecoxib	CELECOXIB	Proficient Rx LP	6dd743d3-4821-4919-90eb-6d306ca7999f	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197

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
205323	celecoxib 200 MG Oral Capsule	PSN	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	7
205323	celecoxib 200 MG Oral Capsule	SCD	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5178-2	50090517802	90 CAPSULE in 1 BOTTLE (50090-5178-2)	90 capsule	2020-09-28	0000-00-00	No	No	Current