Celecoxib

Product NDC: 85534-0067
11-digit product format: 855340067
Labeler code: 85534
Product ID: 85534-0067_562a892c-2da6-2207-e063-6294a90a82a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA205129
Marketing category: ANDA
Marketing start: 2020-12-03
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 · 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
77f3b90b-a25d-4c47-975a-2a988d696a3f	Available on FDA.report

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Medsource Pharmaceuticals	14962aef-7609-b29a-e063-6394a90a5399	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Bryant Ranch Prepack	631154cd-8f61-41b2-a686-80edc711cdaa	2024-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Proficient Rx LP	b9a7f32c-8136-4f29-be6b-4d5e904ca0f1	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Aphena Pharma Solutions - Tennessee, LLC	d258e065-e9a6-44e2-89c9-6892d771d9d3	2021-08-09	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85534-0067-0	85534006700	30 CAPSULE in 1 BOTTLE (85534-0067-0)	30 capsule	2026-09-07	No	No	Current
85534-0067-1	85534006701	60 CAPSULE in 1 BOTTLE (85534-0067-1)	60 capsule	2026-09-07	No	No	Current
85534-0067-2	85534006702	90 CAPSULE in 1 BOTTLE (85534-0067-2)	90 capsule	2026-09-07	No	No	Current
85534-0067-3	85534006703	120 CAPSULE in 1 BOTTLE (85534-0067-3)	120 capsule	2026-09-07	No	No	Current