Celecoxib

Product NDC: 80425-0281
Requested package NDC: 80425-0281-2
11-digit product format: 804250281
Labeler code: 80425
Product ID: 80425-0281_2a9ba8f4-6cea-e827-e063-6394a90a0300
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA210628
Marketing category: ANDA
Marketing start: 2023-03-03
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

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
A210628-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27
A210628-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27
A210628-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27
A210628-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210628-001	AB
A210628-002	AB
A210628-003	AB
A210628-004	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 · 160 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	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A210628-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210628-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210628-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210628-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210628-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210628-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210628-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210628-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210628-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210628-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-004	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: 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f60394f5-fd69-929b-e053-2995a90a5793	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
80425-0281-1	Celecoxib	30 in 1 BOTTLE	CAPSULE	30	2
80425-0281-2	Celecoxib	60 in 1 BOTTLE	CAPSULE	60	2
80425-0281-3	Celecoxib	90 in 1 BOTTLE	CAPSULE	90	2
80425-0281-4	Celecoxib	180 in 1 BOTTLE	CAPSULE	180	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0281-1	EA - Each	80425-0281	8b98e410-0122-4e2a-8d92-b9c6c1702535	1	2023-04-07
80425-0281-2	EA - Each	80425-0281	b47b8b85-db6d-497e-9e03-929c73f5cc54	1	2023-04-07
80425-0281-3	EA - Each	80425-0281	5e59fc25-c69d-4393-9b9e-53b19559dca1	1	2023-04-07
80425-0281-4	EA - Each	80425-0281	51cbb905-70ab-413c-b149-2cf9383403cb	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0281	CELECOXIB CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 4 package rows	20250102_f60394f5-fd69-929b-e053-2995a90a5793.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	fd569104-8243-48fa-8e93-5a08654ad6dd	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
CELECOXIB	CELECOXIB	REMEDYREPACK INC.	d0ca85fa-8b80-4a48-a1a4-a1c181821c39	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	47be1d99-eebb-42f9-80d9-291a024b1364	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
CELECOXIB	CELECOXIB	Umedica Laboratories USA Inc.	b0e0243e-59b3-4f73-8c21-86b60fc7894b	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ae7943ab-b1fc-f08f-e053-2995a90a051e	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
CELECOXIB	CELECOXIB	PHOENIX RX LLC	3a669c28-fbc7-827c-e063-6394a90a0829	2025-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f60394f5-fd69-929b-e053-2995a90a5793	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628 ndc (package): 80425-0281-2 ndc (product): 80425-0281 ndc11 (package): 80425028102

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
205323	celecoxib 200 MG Oral Capsule	PSN	f60394f5-fd69-929b-e053-2995a90a5793	2
205323	celecoxib 200 MG Oral Capsule	SCD	f60394f5-fd69-929b-e053-2995a90a5793	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0281-2	80425028102	60 CAPSULE in 1 BOTTLE (80425-0281-2)	60 capsule	2023-03-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2