Celecoxib

Product NDC: 43353-257
Requested package NDC: 43353-257-60
11-digit product format: 433530257
Labeler code: 43353
Product ID: 43353-257_e3381eee-5310-4f22-ae15-a059905f2c83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078857
Marketing category: ANDA
Marketing start: 2015-11-09
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-257	43353-257-60	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 1 · 2 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	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-257	43353-257-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-257	43353-257-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	Approval date
A078857-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30
A078857-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11
A078857-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11
A078857-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078857-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078857-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078857-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078857-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078857-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078857-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078857-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078857-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078857-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078857-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078857-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078857-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078857-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078857-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078857-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078857-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078857-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078857-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078857-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078857-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078857-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078857-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078857-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078857-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078857-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078857-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078857-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078857-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078857-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078857-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078857-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078857-004	AB	1	`c0c555d07b60…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-257-30	EA - Each	43353-257	cf295bd0-9869-43e1-88cc-26900a88548b	1	2017-10-13
43353-257-53	EA - Each	43353-257	39f9fc03-d645-4de4-a8b1-7a592232237d	1	2017-10-13
43353-257-60	EA - Each	43353-257	d41bc4ef-0dfd-4326-878c-ee85a7e60a36	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-257	CELECOXIB CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20171003_c5f4c4bf-f665-4b07-825a-51cc0ffb1788.zip

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
43353-257-60	43353025760	90 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-60)	90 capsule	2017-06-13	0000-00-00	No	No	Current