Celecoxib

Product NDC: 68788-8206
Requested package NDC: 68788-8206-6
11-digit product format: 687888206
Labeler code: 68788
Product ID: 68788-8206_7f0e6285-dbbf-4999-9635-acea0bd040f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA205129
Marketing category: ANDA
Marketing start: 2023-01-02
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205129-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03
A205129-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03
A205129-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03
A205129-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205129-001	AB
A205129-002	AB
A205129-003	AB
A205129-004	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 · 152 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
2026-09-14 22:38:34	2026-08	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205129-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205129-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205129-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205129-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205129-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205129-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	100 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205322	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
d35d9494-4190-41a8-80d4-c9d877c432e9	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	SPL version
68788-8206-3	Celecoxib	30 in 1 BOTTLE	CAPSULE	30	4
68788-8206-6	Celecoxib	100 in 1 BOTTLE	CAPSULE	100	4
68788-8206-9	Celecoxib	500 in 1 BOTTLE	CAPSULE	500	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8206-3	EA - Each	68788-8206	f2eb48e1-c70d-46d8-97ca-eed4f5273654	1	2023-06-06
68788-8206-6	EA - Each	68788-8206	3424a0a4-a3a7-4d85-aba2-641557bf4948	1	2023-06-06
68788-8206-9	EA - Each	68788-8206	901585ee-8039-4319-9b20-c76de7fd2d37	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8206	CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3	Current NDC, 3 package rows	20250221_d35d9494-4190-41a8-80d4-c9d877c432e9.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	DirectRx	e0f3aacf-df5d-dad7-e053-2995a90ac5eb	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	REMEDYREPACK INC.	b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca8	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	06076494-62ad-4f58-b8bb-7038fcfe3b12	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	HAWAII REPACK, INC.	77f3b90b-a25d-4c47-975a-2a988d696a3f	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	St Mary's Medical Park Pharmacy	e1ab644d-b668-3cf3-e053-2995a90addb0	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Radha Pharmaceuticals, Inc.	2c86ece8-1cf5-4688-91b1-8aef5d60b7e4	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	ST. MARY'S MEDICAL PARK PHARMACY	ed2093f6-1606-100a-e053-2995a90a5b95	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	REMEDYREPACK INC.	56127f57-7810-4f5d-a11d-e08fb2ed138b	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Preferred Pharmaceuticals, Inc.	f2a5ffbd-49c4-4a97-867b-2b14a3675020	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Preferred Pharmaceuticals, Inc.	d35d9494-4190-41a8-80d4-c9d877c432e9	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129 ndc (package): 68788-8206-6 ndc (product): 68788-8206 ndc11 (package): 68788820606
Celecoxib	CELECOXIB	ScieGen Pharmaceuticals, Inc.	8709cbe7-3de1-4908-a0a9-53002bcee15b	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Sportpharm LLC	528a6f12-9878-4005-8fc2-5997adbb287f	2026-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	PHOENIX RX LLC	3a7b127e-c919-418f-e063-6394a90a06d0	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Asclemed USA, Inc.	5d0dcac1-237c-47aa-bcfb-50fa20b5b838	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Quality Care Products, LLC	fcf49d7f-8319-4051-b7ac-fe063268b39b	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0d89c39e-4858-4255-9127-1366e005203c	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0dc9020d-28f5-4c69-896c-87b38e3ddb88	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Bryant Ranch Prepack	8a1e9a52-4627-4098-8a11-25e92ad96023	2024-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	NuCare Pharmaceuticals,Inc.	dfdc74e8-1e4e-53e1-e053-2995a90abc52	2024-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	15d6ef4f-568d-9d3e-e063-6294a90ab04c	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129

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	d35d9494-4190-41a8-80d4-c9d877c432e9	4
205322	celecoxib 100 MG Oral Capsule	SCD	d35d9494-4190-41a8-80d4-c9d877c432e9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8206-6	68788820606	100 CAPSULE in 1 BOTTLE (68788-8206-6)	100 capsule	2023-01-02	No	No	Current