Celecoxib

Product NDC: 68788-7134
11-digit product format: 687887134
Labeler code: 68788
Product ID: 68788-7134_9fe1e50f-38e0-46da-ae47-30ea7b9ce5fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc
Application: ANDA204197
Marketing category: ANDA
Marketing start: 2018-04-10
Marketing end: 0000-00-00
Substance: CELECOXIB
Active strength: 200 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7134		D	Discontinued by firm	2026-08-17
excluded package	package	68788-7134	68788-7134-1	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7134	68788-7134-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7134	68788-7134-6	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7134	68788-7134-8	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7134	68788-7134-9	D	Discontinued by firm	2026-08-17

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 2 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7134-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7134-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7134-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7134-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7134-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7134-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7134-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7134-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7134-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7134-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7134-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7134-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7134-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7134-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7134-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7134-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7134-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7134-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7134-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7134-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7134-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7134-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7134-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7134-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7134-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7134-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7134-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7134-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7134-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7134-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7134-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7134-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7134-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7134-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7134-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7134-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7134-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7134-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7134-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7134-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7134-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7134-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7134-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7134-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7134-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7134-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7134-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7134-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7134-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7134-6	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204197-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02
A204197-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02
A204197-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204197-001	AB
A204197-002	AB
A204197-003	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 · 126 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	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A204197-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204197-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204197-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7134-1	EA - Each	68788-7134	77a7827a-a66e-42df-b99b-1904a933be3a	1	2018-06-11
68788-7134-3	EA - Each	68788-7134	f9d7f181-dbd5-4ea9-ac69-be5977e64b44	1	2018-06-11
68788-7134-6	EA - Each	68788-7134	360d7b37-f011-461f-a343-6338020962d7	1	2018-06-11
68788-7134-8	EA - Each	68788-7134	b471d9c1-bf87-46ee-a54e-c941bf6ef070	1	2018-06-11
68788-7134-9	EA - Each	68788-7134	93025d53-672a-4b63-94f2-59d7befa1837	1	2018-06-11

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Bryant Ranch Prepack	d94849a7-1831-4319-982c-c6b20dc42038	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	52572bfb-43f0-4b55-b1fd-231a05c8b83e	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197
Celecoxib	CELECOXIB	Apotex Corp.	a62612b3-9564-2b34-be59-6aa5ac53679c	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197
Celecoxib	CELECOXIB	A-S Medication Solutions	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197
Celecoxib	CELECOXIB	Proficient Rx LP	6dd743d3-4821-4919-90eb-6d306ca7999f	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197

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	Marketing end	Sample	Exclude flag	Status
68788-7134-1	68788713401	100 CAPSULE in 1 BOTTLE (68788-7134-1)	100 capsule	2018-04-10	0000-00-00	No	No	Current
68788-7134-3	68788713403	30 CAPSULE in 1 BOTTLE (68788-7134-3)	30 capsule	2018-04-10	0000-00-00	No	No	Current
68788-7134-6	68788713406	60 CAPSULE in 1 BOTTLE (68788-7134-6)	60 capsule	2018-04-10	0000-00-00	No	No	Current
68788-7134-8	68788713408	120 CAPSULE in 1 BOTTLE (68788-7134-8)	120 capsule	2018-04-10	0000-00-00	No	No	Current
68788-7134-9	68788713409	90 CAPSULE in 1 BOTTLE (68788-7134-9)	90 capsule	2018-04-10	0000-00-00	No	No	Current