celecoxib

Product NDC: 55700-613
11-digit product format: 557000613
Labeler code: 55700
Product ID: 55700-613_52d20bdb-15ee-4058-81cb-be3f0f1ddfc3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA204590
Marketing category: ANDA
Marketing start: 2018-05-04
Marketing end: 2026-12-31
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
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
A204590-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16
A204590-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16
A204590-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16
A204590-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204590-001	AB
A204590-002	AB
A204590-003	AB
A204590-004	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	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-03-16	`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	A204590-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204590-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204590-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204590-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204590-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204590-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204590-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204590-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204590-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204590-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204590-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204590-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204590-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: celecoxib

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
f0df546e-17c9-4e85-839d-336612d7b9e5	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
55700-613-30	celecoxib	30 in 1 BOTTLE	CAPSULE	30		7
55700-613-60	celecoxib	60 in 1 BOTTLE	CAPSULE	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-613-30	EA - Each	55700-613	77f32146-7389-4682-8536-17c22df3e54c	1	2018-06-11
55700-613-60	EA - Each	55700-613	d72fe023-86b6-412c-8739-0c58ea2f9045	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-613	CELECOXIB CAPSULE [QUALITY CARE PRODUCTS LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250101_f0df546e-17c9-4e85-839d-336612d7b9e5.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
celecoxib	CELECOXIB	HAWAII REPACK, INC.	45816eae-ad83-4d2f-a035-c3f9f24708f9	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	78d59905-4a78-4d9f-ac29-58790a5b3a92	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Macleods Pharmaceuticals Limited	d14aecf5-16e9-459a-bda4-4ca8f290796a	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Preferred Pharmaceuticals Inc.	a6000132-ac6c-4b61-a98a-8cc2dd84b3f0	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Preferred Pharmaceuticals, Inc.	2fc74af6-4573-411d-9082-f3edd44a52a4	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
CELECOXIB	CELECOXIB	Direct Rx	ac87b4f9-3f66-8cf7-e053-2995a90ade0f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Sportpharm LLC	1ae11faa-5bbe-49b7-a4dd-b573c304cf66	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Northwind Health Company, LLC	c213e224-c2fb-726e-e053-2a95a90a21c5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Bryant Ranch Prepack	351f5f07-bdd4-9893-e063-6394a90a7281	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	RedPharm Drug, Inc.	50c29846-3426-0310-e054-00144ff8d46c	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Asclemed USA, Inc.	f6291230-7598-407a-aef0-ec1f09277d2a	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Bryant Ranch Prepack	ac5c0d72-1bb3-4065-b2f4-5516b0869775	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af73fea0-5cd1-0fa2-e053-2a95a90af8fc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	b3545cfb-97c3-b896-e053-2a95a90a15a0	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c8ade384-2072-2cc2-e053-2a95a90ae791	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f8fdd580-09da-9c1c-e053-6394a90a4706	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Quality Care Products LLC	f0df546e-17c9-4e85-839d-336612d7b9e5	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590 ndc (product): 55700-613
celecoxib	CELECOXIB	NuCare Pharmaceuticals,Inc.	69aebbab-9906-be86-e053-2991aa0aa8a5	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Asclemed USA, Inc.	2a926010-08e1-44dd-bc6d-ed15374bd0d3	2023-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590
celecoxib	CELECOXIB	Proficient Rx LP	0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d0	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204590 application number: ANDA204590

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	f0df546e-17c9-4e85-839d-336612d7b9e5	7
205322	celecoxib 100 MG Oral Capsule	SCD	f0df546e-17c9-4e85-839d-336612d7b9e5	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-613-30	55700061330	30 CAPSULE in 1 BOTTLE (55700-613-30)	30 capsule	2018-05-04	2026-12-31	No	No	Current
55700-613-60	55700061360	60 CAPSULE in 1 BOTTLE (55700-613-60)	60 capsule	2018-05-04	2026-12-31	No	No	Current