Celecoxib

Product NDC: 0378-7165
Requested package NDC: 0378-7165-91
11-digit product format: 003787165
Labeler code: 0378
Product ID: 0378-7165_bf30a30a-9307-4319-a5c2-d0f59dfc546e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA078857
Marketing category: ANDA
Marketing start: 2014-05-30
Marketing end: 2023-06-30
Substance: CELECOXIB
Active strength: 50 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: 0000-00-00
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	0378-7165	0378-7165-91	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
0378-7165-01	EA - Each	0378-7165	3d8cf326-de56-4943-a816-6b2cb9e9e093	1	2015-05-05
0378-7165-91	EA - Each	0378-7165	1744ffe8-95d1-424d-9438-5c4e21137150	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]	5

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
0378-7165-91	00378716591	60 CAPSULE in 1 BOTTLE, PLASTIC (0378-7165-91)	60 capsule	2014-05-30	2023-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	Golden State Medical Supply, Inc.	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	8
Celecoxib	Mylan Pharmaceuticals Inc.	2021-06-07	HUMAN PRESCRIPTION DRUG LABEL	15