Celecoxib

Product NDC: 45865-840
11-digit product format: 458650840
Labeler code: 45865
Product ID: 45865-840_9ab47faa-a90e-a695-e053-2a95a90a270e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: NDA020998
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-12-10
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-840		I	Inactivated by FDA	2026-08-10
excluded package	package	45865-840	45865-840-30	I	Inactivated by FDA	2026-08-10
excluded package	package	45865-840	45865-840-60	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 · 48 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	45865-840-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-840-60	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	45865-840-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-840-60	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	45865-840-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-840-60	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	45865-840-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-840-60	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	45865-840-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-840-60	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	45865-840-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-840-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-840-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-840-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-840-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-840-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-840-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-840-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-840-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-840-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45865-840-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45865-840-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45865-840-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45865-840-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45865-840-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45865-840-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45865-840-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45865-840-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45865-840-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45865-840-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45865-840-60	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45865-840-30	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`

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	RLD / RS	Approval date
N020998-001	CELEBREX	CELECOXIB	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31
N020998-002	CELEBREX	CELECOXIB	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31
N020998-003	CELEBREX	CELECOXIB	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29
N020998-004	CELEBREX	CELECOXIB	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020998-001	AB
N020998-002	AB
N020998-003	AB
N020998-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020998-001	CELEBREX	100MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020998-002	CELEBREX	200MG	CAPSULE / ORAL	AB	RLD	1998-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020998-003	CELEBREX	400MG	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020998-004	CELEBREX	50MG	CAPSULE / ORAL	AB	RLD	2006-12-15	`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	N020998-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020998-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020998-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020998-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020998-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020998-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020998-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020998-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020998-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020998-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020998-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020998-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020998-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020998-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020998-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020998-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020998-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020998-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020998-004	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
45865-840-30	2023-01-30	C162847	48780-1	f386c649-a749-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib Capsules Initial U.S. Approval: 1998
45865-840-60	2023-01-30	C162847	48780-1	f386c649-a749-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib Capsules Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-840-30	Celecoxib	30 in 1 BOTTLE	CAPSULE	30		2
45865-840-60	Celecoxib	60 in 1 BOTTLE	CAPSULE	60		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-840	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20191228_2087ead6-69b3-5f5a-e054-00144ff8d46c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELEBREX	CELECOXIB	Viatris Specialty LLC	2d6675e4-5859-4be2-8037-a20ce9f707aa	2024-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020998 application number: NDA020998

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	2087ead6-69b3-5f5a-e054-00144ff8d46c	2
205323	celecoxib 200 MG Oral Capsule	SCD	2087ead6-69b3-5f5a-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-840-30	45865084030	30 CAPSULE in 1 BOTTLE (45865-840-30)	30 capsule	2015-09-24	0000-00-00	No	No	Current
45865-840-60	45865084060	60 CAPSULE in 1 BOTTLE (45865-840-60)	60 capsule	2015-09-24	0000-00-00	No	No	Current