Celecoxib

Product NDC: 65862-909
Requested package NDC: 65862-909-05
11-digit product format: 658620909
Labeler code: 65862
Product ID: 65862-909_5969bc02-84f8-41e5-a6b5-abcb6a985591
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA206827
Marketing category: ANDA
Marketing start: 2016-02-01
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
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A206827-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01
A206827-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01
A206827-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01
A206827-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206827-001	AB
A206827-002	AB
A206827-003	AB
A206827-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206827-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206827-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206827-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206827-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206827-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206827-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206827-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib
Listing expiration: 2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205322	Internal RxNorm lookup
205323	Internal RxNorm lookup
349514	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
1e811c3a-5653-4617-b958-380802cc443a	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-909-01	Celecoxib	100 in 1 BOTTLE	CAPSULE	100	9
65862-909-05	Celecoxib	500 in 1 BOTTLE	CAPSULE	500	9
65862-909-99	Celecoxib	1000 in 1 BOTTLE	CAPSULE	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-909-01	EA - Each	65862-909	c1e1be1b-34e0-4f1a-b4a4-fefc0b5d11a6	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-909	CELECOXIB CAPSULE [AUROBINDO PHARMA LIMITED]	9	Current NDC, Legacy NDC, 3 package rows	20241215_1e811c3a-5653-4617-b958-380802cc443a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	REMEDYREPACK INC.	e18d2fa4-4982-4e2a-af55-4319d6416efb	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206827 application number: ANDA206827
Celecoxib	CELECOXIB	NCS HealthCare of KY, LLC dba Vangard Labs	34bef49c-eca1-4f17-9b1b-55900ac40829	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206827 application number: ANDA206827
Celecoxib	CELECOXIB	Aurobindo Pharma Limited	1e811c3a-5653-4617-b958-380802cc443a	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206827 application number: ANDA206827 ndc (package): 65862-909-05 ndc (product): 65862-909 ndc11 (package): 65862090905

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
205322	celecoxib 100 MG Oral Capsule	PSN	1e811c3a-5653-4617-b958-380802cc443a	9
205323	celecoxib 200 MG Oral Capsule	PSN	1e811c3a-5653-4617-b958-380802cc443a	9
349514	celecoxib 400 MG Oral Capsule	PSN	1e811c3a-5653-4617-b958-380802cc443a	9
686379	celecoxib 50 MG Oral Capsule	PSN	1e811c3a-5653-4617-b958-380802cc443a	9
205322	celecoxib 100 MG Oral Capsule	SCD	1e811c3a-5653-4617-b958-380802cc443a	9
205323	celecoxib 200 MG Oral Capsule	SCD	1e811c3a-5653-4617-b958-380802cc443a	9
349514	celecoxib 400 MG Oral Capsule	SCD	1e811c3a-5653-4617-b958-380802cc443a	9
686379	celecoxib 50 MG Oral Capsule	SCD	1e811c3a-5653-4617-b958-380802cc443a	9
205322	celecoxib 100 MG Oral Capsule	PSN	34bef49c-eca1-4f17-9b1b-55900ac40829	1
205323	celecoxib 200 MG Oral Capsule	PSN	03c40e1c-c274-48d9-9c70-5f2a670e49cc	1
205323	celecoxib 200 MG Oral Capsule	PSN	34bef49c-eca1-4f17-9b1b-55900ac40829	1
205322	celecoxib 100 MG Oral Capsule	SCD	34bef49c-eca1-4f17-9b1b-55900ac40829	1
205323	celecoxib 200 MG Oral Capsule	SCD	03c40e1c-c274-48d9-9c70-5f2a670e49cc	1
205323	celecoxib 200 MG Oral Capsule	SCD	34bef49c-eca1-4f17-9b1b-55900ac40829	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-909-05	65862090905	500 CAPSULE in 1 BOTTLE (65862-909-05)	500 capsule	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	REMEDYREPACK INC.	2026-08-14	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	NCS HealthCare of KY, LLC dba Vangard Labs	2025-02-20	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	Aurobindo Pharma Limited	2024-12-05	Human Prescription Drug Label	9
Celecoxib	Preferred Pharmaceuticals Inc.	2019-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
Celecoxib	A-S Medication Solutions	2018-04-18	Human Prescription Drug Label	5
Celecoxib	Cambridge Therapeutics Technologies, LLC	2017-06-20	HUMAN PRESCRIPTION DRUG LABEL	1