Celecoxib

Product NDC: 60505-3849
11-digit product format: 605053849
Labeler code: 60505
Product ID: 60505-3849_3f02b96b-79f0-71a0-fd31-ab495401b187
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA204197
Marketing category: ANDA
Marketing start: 2015-06-03
Marketing end: 2027-05-31
Substance: CELECOXIB
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-3849	60505-3849-3	D	Discontinued by firm		2026-08-17
excluded package	package	60505-3849	60505-3849-8	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	60505-3849-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-3849-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-3849-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-3849-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-3849-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-3849-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-3849-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-3849-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-3849-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-3849-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-3849-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-3849-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-3849-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-3849-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-3849-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-3849-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-3849-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-3849-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	60505-3849-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	60505-3849-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	60505-3849-8	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	60505-3849-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	60505-3849-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	60505-3849-3	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JCX84Q7J1L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205322	Internal RxNorm lookup
205323	Internal RxNorm lookup
686379	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a62612b3-9564-2b34-be59-6aa5ac53679c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-3849-1	Celecoxib	100 in 1 BOTTLE	CAPSULE	100	25
60505-3849-3	Celecoxib	30 in 1 BOTTLE	CAPSULE	30	25
60505-3849-5	Celecoxib	500 in 1 BOTTLE	CAPSULE	500	25
60505-3849-8	Celecoxib	1000 in 1 BOTTLE	CAPSULE	1000	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3849-1	EA - Each	60505-3849	d5605868-1f41-4ca1-a737-f4f1292898a5	1	2015-07-20
60505-3849-5	EA - Each	60505-3849	7389baf4-e339-4f25-8df0-8958d352565d	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Celecoxib	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [APOTEX CORP.]	11
Celecoxib	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [APOTEX CORP.]	11
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [APOTEX CORP.]	11
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [APOTEX CORP.]	11
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [APOTEX CORP.]	11
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [APOTEX CORP.]	11
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [APOTEX CORP.]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CELECOXIB CAPSULE [APOTEX CORP.]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CELECOXIB CAPSULE [APOTEX CORP.]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [APOTEX CORP.]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [APOTEX CORP.]	11
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [APOTEX CORP.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [APOTEX CORP.]	11
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [APOTEX CORP.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [APOTEX CORP.]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [APOTEX CORP.]	11
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CELECOXIB CAPSULE [APOTEX CORP.]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [APOTEX CORP.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [APOTEX CORP.]	11
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Celecoxib	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Celecoxib	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
POVIDONE K12	INACTIVE INGREDIENT	333AG72FWJ	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3849	CELECOXIB CAPSULE [APOTEX CORP.]	24	Current NDC, Legacy NDC, 4 package rows	20250302_a62612b3-9564-2b34-be59-6aa5ac53679c.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 · 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 ndc (product): 60505-3849
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205323	celecoxib 200 MG Oral Capsule	PSN	52572bfb-43f0-4b55-b1fd-231a05c8b83e	32
205323	celecoxib 200 MG Oral Capsule	SCD	52572bfb-43f0-4b55-b1fd-231a05c8b83e	32
205322	celecoxib 100 MG Oral Capsule	PSN	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205323	celecoxib 200 MG Oral Capsule	PSN	a62612b3-9564-2b34-be59-6aa5ac53679c	25
686379	celecoxib 50 MG Oral Capsule	PSN	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205322	celecoxib 100 MG Oral Capsule	SCD	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205323	celecoxib 200 MG Oral Capsule	SCD	a62612b3-9564-2b34-be59-6aa5ac53679c	25
686379	celecoxib 50 MG Oral Capsule	SCD	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205322	celecoxib 100 MG Oral Capsule	PSN	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205322	celecoxib 100 MG Oral Capsule	PSN	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	PSN	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205323	celecoxib 200 MG Oral Capsule	PSN	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205322	celecoxib 100 MG Oral Capsule	SCD	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205322	celecoxib 100 MG Oral Capsule	SCD	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	SCD	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	SCD	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205323	celecoxib 200 MG Oral Capsule	PSN	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	7
205323	celecoxib 200 MG Oral Capsule	SCD	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	7
205323	celecoxib 200 MG Oral Capsule	PSN	6c56cfd5-f5e2-cbdd-e053-2991aa0a2e1a	4
205323	celecoxib 200 MG Oral Capsule	SCD	6c56cfd5-f5e2-cbdd-e053-2991aa0a2e1a	4
205323	celecoxib 200 MG Oral Capsule	PSN	6dd743d3-4821-4919-90eb-6d306ca7999f	3
205323	celecoxib 200 MG Oral Capsule	SCD	6dd743d3-4821-4919-90eb-6d306ca7999f	3
205323	celecoxib 200 MG Oral Capsule	PSN	a76b143e-70c7-41da-b40b-adee661f0a60	2
205323	celecoxib 200 MG Oral Capsule	PSN	23e5c271-3d06-5a63-e054-00144ff8d46c	2
205323	celecoxib 200 MG Oral Capsule	SCD	a76b143e-70c7-41da-b40b-adee661f0a60	2
205323	celecoxib 200 MG Oral Capsule	SCD	23e5c271-3d06-5a63-e054-00144ff8d46c	2
205323	celecoxib 200 MG Oral Capsule	PSN	8e859901-e41c-420b-e053-2995a90ae09a	1
205323	celecoxib 200 MG Oral Capsule	PSN	56d1e6f1-7b59-3d73-e054-00144ff8d46c	1
205323	celecoxib 200 MG Oral Capsule	SCD	8e859901-e41c-420b-e053-2995a90ae09a	1
205323	celecoxib 200 MG Oral Capsule	SCD	56d1e6f1-7b59-3d73-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3849-1	60505384901	100 CAPSULE in 1 BOTTLE (60505-3849-1)	100 capsule	2015-06-03	2027-05-31	No	No	Current
60505-3849-3	60505384903	30 CAPSULE in 1 BOTTLE (60505-3849-3)	30 capsule	2015-06-03	0000-00-00	No	No	Current
60505-3849-5	60505384905	500 CAPSULE in 1 BOTTLE (60505-3849-5)	500 capsule	2015-06-03	2027-03-31	No	No	Current
60505-3849-8	60505384908	1000 CAPSULE in 1 BOTTLE (60505-3849-8)	1000 capsule	2015-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	PD-Rx Pharmaceuticals, Inc.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	32
Celecoxib	Apotex Corp. \| Apotex Inc.	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	25
Celecoxib	Major Pharmaceuticals	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	9
Celecoxib	A-S Medication Solutions	2024-09-18	HUMAN PRESCRIPTION DRUG LABEL	7
CELECOXIB	Direct_Rx	2023-04-18	HUMAN PRESCRIPTION DRUG LABEL	9
Celecoxib	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2022-01-25	HUMAN PRESCRIPTION DRUG LABEL	8
celecoxib 200	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	4
NuDroxiPAK	NuCare Pharmaceuticals,Inc.	2021-07-28	HUMAN PRESCRIPTION DRUG LABEL	4
Celecoxib	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Celecoxib	Preferred Pharmaceuticals Inc	2020-04-14	HUMAN PRESCRIPTION DRUG LABEL	3
Celecoxib	St. Mary's Medical Park Pharmacy \| Apotex Inc. \| Apotex Research Private Limited	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	4
CELECOXIB 200mg	Direct_Rx	2019-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	NuCare Pharmaceuticals,Inc.	2018-01-24	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	NuCare Pharmaceuticals,Inc. \| NuCare Pharamceutiacals,Inc.	2017-12-11	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	Unit Dose Services	2017-08-16	HUMAN PRESCRIPTION DRUG LABEL	2
Celecoxib	Mas Management Group, Inc.	2017-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	Blenheim Pharmacal, Inc.	2016-04-21	HUMAN PRESCRIPTION DRUG LABEL	2