Celecoxib

Product NDC: 50268-169
11-digit product format: 502680169
Labeler code: 50268
Product ID: 50268-169_5245a7d8-0271-b4bf-e063-6294a90a34a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA204519
Marketing category: ANDA
Marketing start: 2019-10-17
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: 2027-12-31
Current FDA listing: Yes

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
A204519-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21
A204519-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21
A204519-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21
A204519-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204519-001	AB
A204519-002	AB
A204519-003	AB
A204519-004	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	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-08-21	`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	A204519-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204519-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204519-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204519-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204519-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204519-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204519-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204519-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204519-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204519-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204519-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205322	Internal RxNorm lookup
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
951df0f7-5fb7-40f5-e053-2995a90a1edd	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-169-11	Celecoxib	1 in 1 BLISTER PACK	CAPSULE	1		6
50268-169-15	Celecoxib	50 in 1 BOX	CAPSULE	50		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-169-11	EA - Each	50268-169	fa0a5e24-6d86-4074-aae5-bf49fcc501c8	1	2019-11-12
50268-169-15	EA - Each	50268-169	1fd020e4-3d18-4c54-9d1d-0bbb75ab85b3	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-169	CELECOXIB CAPSULE [AVPAK]	4	Current NDC, Legacy NDC, 2 package rows	20220507_951df0f7-5fb7-40f5-e053-2995a90a1edd.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Alembic Pharmaceuticals Inc.	806e5f8a-f986-4f88-ba3e-8265f86afa48	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Cardinal Health 107, LLC	a9114d6a-13d7-443c-be44-7866b4a4cf96	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	AvPAK	951df0f7-5fb7-40f5-e053-2995a90a1edd	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519 ndc (product): 50268-169
Celecoxib	CELECOXIB	Major Pharmaceuticals	3a1eadd5-c0a7-473e-bde0-6b9450d11c95	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	RedPharm Drug	2fbaa580-f33a-417d-e063-6294a90ad7df	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Alembic Pharmaceuticals Limited	14e8d788-e44c-4a40-8678-25cf45fed477	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib 200 mg	CELECOXIB	Proficient Rx LP	feee6a01-63f9-42c3-8bd8-ca713a08b36d	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Proficient Rx LP	7a234c0c-30a7-49f5-92a1-a1fc836ff9ae	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519
Celecoxib	CELECOXIB	Proficient Rx LP	c787b0ab-77ab-4f7e-9fea-be2a0085020a	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204519 application number: ANDA204519

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	951df0f7-5fb7-40f5-e053-2995a90a1edd	6
205323	celecoxib 200 MG Oral Capsule	PSN	951df0f7-5fb7-40f5-e053-2995a90a1edd	6
205322	celecoxib 100 MG Oral Capsule	SCD	951df0f7-5fb7-40f5-e053-2995a90a1edd	6
205323	celecoxib 200 MG Oral Capsule	SCD	951df0f7-5fb7-40f5-e053-2995a90a1edd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-169-11	50268016911	1 in 1 BLISTER PACK						Historical
50268-169-15	50268016915	50 BLISTER PACK in 1 BOX (50268-169-15) / 1 CAPSULE in 1 BLISTER PACK (50268-169-11)	50 blister pack	2019-10-17	0000-00-00	No	No	Current