Celecoxib

Product NDC: 68071-2776
11-digit product format: 680712776
Labeler code: 68071
Product ID: 68071-2776_e2ad4228-9de2-5b5c-e053-2995a90ad6a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA205129
Marketing category: ANDA
Marketing start: 2020-12-03
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-2776		I	Inactivated by FDA	2026-08-10
excluded package	package	68071-2776	68071-2776-2	I	Inactivated by FDA	2026-08-10
excluded package	package	68071-2776	68071-2776-3	I	Inactivated by FDA	2026-08-10

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2776-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2776-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2776-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2776-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2776-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2776-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2776-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2776-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2776-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2776-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2776-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2776-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2776-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2776-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2776-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2776-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2776-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2776-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 144 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205129-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-004	AB	1	`d06236e962d9…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2776-2	2025-01-30	C162847	48780-1	2cef2736-8199-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
68071-2776-3	2025-01-30	C162847	48780-1	2cef2736-8199-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2776-2	Celecoxib	22 in 1 BOTTLE	CAPSULE	22		2
68071-2776-3	Celecoxib	30 in 1 BOTTLE	CAPSULE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2776	CELECOXIB CAPSULE [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 2 package rows	20231207_e2ad2dae-311d-7b9c-e053-2995a90aa380.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	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	REMEDYREPACK INC.	b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca8	2026-04-15	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
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	DirectRx	e0f3aacf-df5d-dad7-e053-2995a90ac5eb	2025-01-22	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	e2ad2dae-311d-7b9c-e053-2995a90aa380	2
205322	celecoxib 100 MG Oral Capsule	SCD	e2ad2dae-311d-7b9c-e053-2995a90aa380	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2776-2	68071277602	22 in 1 BOTTLE						Historical
68071-2776-3	68071277603	30 CAPSULE in 1 BOTTLE (68071-2776-3)	30 capsule	2022-06-30	0000-00-00	No	No	Current