Celecoxib

Product NDC: 0591-3985
Requested package NDC: 0591-3985-60
11-digit product format: 005913985
Labeler code: 0591
Product ID: 0591-3985_3800c0c9-73b4-45a2-a2d4-7f33fd858b56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA200562
Marketing category: ANDA
Marketing start: 2015-03-12
Marketing end: 0000-00-00
Substance: CELECOXIB
Active strength: 400 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	0591-3985	0591-3985-60	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
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…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	400 mg/1

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
0591-3985-60	Celecoxib	60 in 1 BOTTLE	CAPSULE	60		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3985-60	EA - Each	0591-3985	d8809f0c-3e8a-443e-9361-c96feba43265	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3985	CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]	20	Legacy NDC, 1 package rows	20250411_05224473-27dc-4f6d-a52a-c40a7af2f2f4.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 ndc (package): 0591-3985-60 ndc (product): 0591-3985 ndc11 (package): 00591398560
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	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
205323	celecoxib 200 MG Oral Capsule	PSN	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
349514	celecoxib 400 MG Oral Capsule	PSN	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
686379	celecoxib 50 MG Oral Capsule	PSN	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
205322	celecoxib 100 MG Oral Capsule	SCD	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
205323	celecoxib 200 MG Oral Capsule	SCD	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
349514	celecoxib 400 MG Oral Capsule	SCD	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
686379	celecoxib 50 MG Oral Capsule	SCD	05224473-27dc-4f6d-a52a-c40a7af2f2f4	21
205322	celecoxib 100 MG Oral Capsule	PSN	265b50cc-6d99-4ef8-8439-6792e1f21c68	1
205323	celecoxib 200 MG Oral Capsule	PSN	265b50cc-6d99-4ef8-8439-6792e1f21c68	1
349514	celecoxib 400 MG Oral Capsule	PSN	265b50cc-6d99-4ef8-8439-6792e1f21c68	1
686379	celecoxib 50 MG Oral Capsule	PSN	265b50cc-6d99-4ef8-8439-6792e1f21c68	1
205322	celecoxib 100 MG Oral Capsule	SCD	265b50cc-6d99-4ef8-8439-6792e1f21c68	1
205323	celecoxib 200 MG Oral Capsule	SCD	265b50cc-6d99-4ef8-8439-6792e1f21c68	1
349514	celecoxib 400 MG Oral Capsule	SCD	265b50cc-6d99-4ef8-8439-6792e1f21c68	1
686379	celecoxib 50 MG Oral Capsule	SCD	265b50cc-6d99-4ef8-8439-6792e1f21c68	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3985-60	00591398560	60 CAPSULE in 1 BOTTLE (0591-3985-60)	60 capsule	2015-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	Actavis Pharma, Inc.	2025-04-30	HUMAN PRESCRIPTION DRUG LABEL	21
Celecoxib	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-05-10	HUMAN PRESCRIPTION DRUG LABEL	1