Celecoxib

Product NDC: 80425-0039
11-digit product format: 804250039
Labeler code: 80425
Product ID: 80425-0039_2a987a87-35f5-e046-e063-6294a90aa7c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA207446
Marketing category: ANDA
Marketing start: 2017-09-26
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	80425-0039		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	80425-0039	80425-0039-1	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	80425-0039	80425-0039-2	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207446-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23
A207446-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23
A207446-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23
A207446-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207446-001	AB
A207446-002	AB
A207446-003	AB
A207446-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207446-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-004	AB	1	`d06236e962d9…`

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
af9d962a-5469-2039-e053-2a95a90ad59f	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
80425-0039-1	Celecoxib	30 in 1 BOTTLE	CAPSULE	30		8
80425-0039-2	Celecoxib	60 in 1 BOTTLE	CAPSULE	60		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0039-1	EA - Each	80425-0039	c3c7ec55-fa74-4499-a5a0-ae5b3d8a93f8	1	2023-03-13
80425-0039-2	EA - Each	80425-0039	bc23629b-0a1d-4c58-9623-ccc65229ab8d	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0039	CELECOXIB CAPSULE [ADVANCED RX OF TENNESSEE, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20250101_af9d962a-5469-2039-e053-2a95a90ad59f.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELECOXIB	CELECOXIB	REMEDYREPACK INC.	27f17ae7-939b-402e-9498-3b6611104089	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	f874eddf-b2f3-6830-e053-6394a90ade7a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	f2a0db9f-174b-1603-e053-2995a90a79a3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	A-S Medication Solutions	95b2ced1-eca2-4c25-aa10-c9fb86b353a3	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	A-S Medication Solutions	7b8e923c-253f-461e-94d7-669e75dc73e9	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	3191c9dc-bfdf-0591-e054-00144ff8d46c	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Quallent Pharmaceuticals Health LLC	aaa3a4f5-b281-415f-a08c-e0cefdae2fb5	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Cipla USA Inc.	d12625b1-2af9-4532-af91-d40b65eeffef	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	NorthStar RxLLC	ce61a585-5ac0-4185-99eb-a9511cd25a98	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af9d962a-5469-2039-e053-2a95a90ad59f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446 ndc (product): 80425-0039
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c1abc73e-c6ab-a0a5-e053-2a95a90a0817	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Proficient Rx LP	c91e5933-1798-4096-9f08-fb1200e154e1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446

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	af9d962a-5469-2039-e053-2a95a90ad59f	8
205323	celecoxib 200 MG Oral Capsule	SCD	af9d962a-5469-2039-e053-2a95a90ad59f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0039-1	80425003901	30 CAPSULE in 1 BOTTLE (80425-0039-1)	30 capsule	2017-09-26	0000-00-00	No	No	Current
80425-0039-2	80425003902	60 CAPSULE in 1 BOTTLE (80425-0039-2)	60 capsule	2017-09-26	0000-00-00	No	No	Current