Celecoxib

Product NDC: 50436-3983
Requested package NDC: 50436-3983-1
11-digit product format: 504363983
Labeler code: 50436
Product ID: 50436-3983_a360f53f-e638-445f-9fe2-9bf11baa7c0c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA200562
Marketing category: ANDA
Marketing start: 2015-03-12
Marketing end: 0000-00-00
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50436-3983	50436-3983-1	I	Inactivated by FDA		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 · 19 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A200562-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11
A200562-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11
A200562-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11
A200562-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200562-001	AB
A200562-002	AB
A200562-003	AB
A200562-004	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	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`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	A200562-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200562-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200562-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-004	AB	1	`d8e5a09893c0…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-3983-1	2024-01-30	C162847	48780-1	ba0f9c33-5561-a910-e053-dadaa90a0b85	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
50436-3983-1	2022-10-17	C162847	48780-1	ba0f9c33-5561-a910-e053-dadaa90a0b85	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
50436-3983-1	2021-01-29	C162847	48780-1	ba0f9c33-5561-a910-e053-dadaa90a0b85	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	Strength	SPL version
50436-3983-1	Celecoxib	30 in 1 BOTTLE	CAPSULE	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-3983-1	EA - Each	50436-3983	f8d50cfb-6f8d-4076-9d5c-161cb8e7e905	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3983	CELECOXIB CAPSULE [UNIT DOSE SERVICES]	6	Legacy NDC, 1 package rows	20221018_298dd3a8-2cec-4260-961a-6294d08eecf7.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Actavis Pharma, Inc.	05224473-27dc-4f6d-a52a-c40a7af2f2f4	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200562 application number: ANDA200562
Celecoxib	CELECOXIB	Asclemed USA, Inc.	265b50cc-6d99-4ef8-8439-6792e1f21c68	2024-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200562 application number: ANDA200562
Celecoxib	CELECOXIB	Proficient Rx LP	c529b321-38ed-434f-b76e-06902cdd40dc	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200562 application number: ANDA200562

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	298dd3a8-2cec-4260-961a-6294d08eecf7	6
205323	celecoxib 200 MG Oral Capsule	PSN	298dd3a8-2cec-4260-961a-6294d08eecf7	6
205322	celecoxib 100 MG Oral Capsule	SCD	298dd3a8-2cec-4260-961a-6294d08eecf7	6
205323	celecoxib 200 MG Oral Capsule	SCD	298dd3a8-2cec-4260-961a-6294d08eecf7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-3983-1	50436398301	30 CAPSULE in 1 BOTTLE (50436-3983-1)	30 capsule	2017-08-04	0000-00-00	No	No	Current