Celecoxib

Product NDC: 71209-056
11-digit product format: 712090056
Labeler code: 71209
Product ID: 71209-056_491c8284-c565-4c6b-8d88-4373b179be4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Cadila Pharmaceuticals Limited
Application: ANDA208701
Marketing category: ANDA
Marketing start: 2015-12-15
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
A208701-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14
A208701-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14
A208701-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14
A208701-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208701-001	AB
A208701-002	AB
A208701-003	AB
A208701-004	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 4 · 160 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	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A208701-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208701-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208701-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208701-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208701-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208701-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208701-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-004	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
78ce3df5-07ee-43bb-9348-104a9524a032	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
71209-056-03	Celecoxib	60 in 1 BOTTLE	CAPSULE	60	14
71209-056-05	Celecoxib	100 in 1 BOTTLE	CAPSULE	100	14
71209-056-10	Celecoxib	500 in 1 BOTTLE	CAPSULE	500	14
71209-056-11	Celecoxib	1000 in 1 BOTTLE	CAPSULE	1000	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71209-056	CELECOXIB CAPSULE [CADILA PHARMACEUTICALS LIMITED]	14	Current NDC, Legacy NDC, 4 package rows	20241212_78ce3df5-07ee-43bb-9348-104a9524a032.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	REMEDYREPACK INC.	56d64558-1fad-420e-8fcd-7103cd073127	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701
Celecoxib	CELECOXIB	Modavar Pharmaceuticals LLC	b0f73074-f3d8-4812-8e64-f88a02869ed3	2024-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701
Celecoxib	CELECOXIB	Cadila Pharmaceuticals Limited	78ce3df5-07ee-43bb-9348-104a9524a032	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701 ndc (product): 71209-056
Celecoxib	CELECOXIB	Bryant Ranch Prepack	1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6	2024-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701

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	78ce3df5-07ee-43bb-9348-104a9524a032	14
205323	celecoxib 200 MG Oral Capsule	PSN	78ce3df5-07ee-43bb-9348-104a9524a032	14
349514	celecoxib 400 MG Oral Capsule	PSN	78ce3df5-07ee-43bb-9348-104a9524a032	14
686379	celecoxib 50 MG Oral Capsule	PSN	78ce3df5-07ee-43bb-9348-104a9524a032	14
205322	celecoxib 100 MG Oral Capsule	SCD	78ce3df5-07ee-43bb-9348-104a9524a032	14
205323	celecoxib 200 MG Oral Capsule	SCD	78ce3df5-07ee-43bb-9348-104a9524a032	14
349514	celecoxib 400 MG Oral Capsule	SCD	78ce3df5-07ee-43bb-9348-104a9524a032	14
686379	celecoxib 50 MG Oral Capsule	SCD	78ce3df5-07ee-43bb-9348-104a9524a032	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71209-056-03	71209005603	60 CAPSULE in 1 BOTTLE (71209-056-03)	60 capsule	2018-08-23	0000-00-00	No	No	Current
71209-056-05	71209005605	100 CAPSULE in 1 BOTTLE (71209-056-05)	100 capsule	2021-09-10	0000-00-00	No	No	Current
71209-056-10	71209005610	500 CAPSULE in 1 BOTTLE (71209-056-10)	500 capsule	2021-09-10	0000-00-00	No	No	Current
71209-056-11	71209005611	1000 CAPSULE in 1 BOTTLE (71209-056-11)	1000 capsule	2018-08-23	0000-00-00	No	No	Current