Celecoxib

Product NDC: 0904-6503
11-digit product format: 009046503
Labeler code: 0904
Product ID: 0904-6503_945b6833-914c-4ec8-a9fa-2384b6483ea9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA204197
Marketing category: ANDA
Marketing start: 2015-06-25
Marketing end: 2026-06-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-6503		D	Discontinued by firm		2026-08-17
excluded package	package	0904-6503	0904-6503-61	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 · 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…`

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
0904-6503-61	Celecoxib	1 in 1 BLISTER PACK	CAPSULE	1		9
0904-6503-61	Celecoxib	100 in 1 CARTON	CAPSULE	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6503-61	EA - Each	0904-6503	bce7b3a8-d461-464c-927a-a24b70c06687	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
POVIDONE K12	INACTIVE INGREDIENT	333AG72FWJ	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6503	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20250316_370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46.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
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
205322	celecoxib 100 MG Oral Capsule	PSN	a4bc991b-ed27-4f52-a4c7-3b83a1af1739	12
205323	celecoxib 200 MG Oral Capsule	PSN	a4bc991b-ed27-4f52-a4c7-3b83a1af1739	12
205322	celecoxib 100 MG Oral Capsule	SCD	a4bc991b-ed27-4f52-a4c7-3b83a1af1739	12
205323	celecoxib 200 MG Oral Capsule	SCD	a4bc991b-ed27-4f52-a4c7-3b83a1af1739	12
205322	celecoxib 100 MG Oral Capsule	PSN	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	PSN	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205322	celecoxib 100 MG Oral Capsule	SCD	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	SCD	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6503-61	00904650361	100 BLISTER PACK in 1 CARTON (0904-6503-61) / 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2015-06-25	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	Cardinal Health 107, LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	12
Celecoxib	Major Pharmaceuticals	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	9