Celecoxib

Product NDC: 42806-722
Requested package NDC: 42806-722-05
11-digit product format: 428060722
Labeler code: 42806
Product ID: 42806-722_2b20721c-b138-1932-e063-6394a90ae66e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: EPIC PHARMA, LLC
Application: ANDA207872
Marketing category: ANDA
Marketing start: 2020-10-16
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
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42806-722	42806-722-05	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207872-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25
A207872-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25
A207872-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25
A207872-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207872-001	AB
A207872-002	AB
A207872-003	AB
A207872-004	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 4 · 148 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
2026-02-19 14:30 UTC	2026-02	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207872-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207872-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207872-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207872-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207872-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207872-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib
Listing expiration: 2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205322	Internal RxNorm lookup
205323	Internal RxNorm lookup
349514	Internal RxNorm lookup
686379	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
ac670924-0a3f-4f94-ac01-9e3c3071c990	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
42806-722-01	2022-12-28	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
42806-722-05	2022-12-28	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
42806-722-01	2022-07-29	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
42806-722-05	2022-07-29	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
42806-722-01	Celecoxib	100 in 1 BOTTLE	CAPSULE	100		3
42806-722-05	Celecoxib	500 in 1 BOTTLE	CAPSULE	500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-722	CELECOXIB (CELECOXIB) CAPSULE [EPIC PHARMA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20250109_ac670924-0a3f-4f94-ac01-9e3c3071c990.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	EPIC PHARMA, LLC	ac670924-0a3f-4f94-ac01-9e3c3071c990	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207872 application number: ANDA207872 ndc (package): 42806-722-05 ndc (product): 42806-722 ndc11 (package): 42806072205
Celecoxib	CELECOXIB	Tianjin Tianyao Pharmaceuticals Co., Ltd.	76f9bcb7-0e94-485f-816d-61d4e1ed24e0	2022-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207872 application number: ANDA207872

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	ac670924-0a3f-4f94-ac01-9e3c3071c990	3
205323	celecoxib 200 MG Oral Capsule	PSN	ac670924-0a3f-4f94-ac01-9e3c3071c990	3
349514	celecoxib 400 MG Oral Capsule	PSN	ac670924-0a3f-4f94-ac01-9e3c3071c990	3
686379	celecoxib 50 MG Oral Capsule	PSN	ac670924-0a3f-4f94-ac01-9e3c3071c990	3
205322	celecoxib 100 MG Oral Capsule	SCD	ac670924-0a3f-4f94-ac01-9e3c3071c990	3
205323	celecoxib 200 MG Oral Capsule	SCD	ac670924-0a3f-4f94-ac01-9e3c3071c990	3
349514	celecoxib 400 MG Oral Capsule	SCD	ac670924-0a3f-4f94-ac01-9e3c3071c990	3
686379	celecoxib 50 MG Oral Capsule	SCD	ac670924-0a3f-4f94-ac01-9e3c3071c990	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42806-722-05	42806072205	500 CAPSULE in 1 BOTTLE (42806-722-05)	500 capsule	2020-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	EPIC PHARMA, LLC \| Tianjin Kingyork Pharmaceuticals Co., Ltd.	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	3