CELECOXIB

Product NDC: 42571-145
11-digit product format: 425710145
Labeler code: 42571
Product ID: 42571-145_350160e1-34ab-f7e3-e063-6394a90a4508
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA204776
Marketing category: ANDA
Marketing start: 2018-06-01
Substance: CELECOXIB
Active strength: 400 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 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	Approval date
A204776-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30
A204776-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30
A204776-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30
A204776-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204776-001	AB
A204776-002	AB
A204776-003	AB
A204776-004	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204776-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204776-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204776-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204776-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2018-04-30	`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	A204776-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204776-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204776-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204776-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204776-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204776-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204776-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204776-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204776-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204776-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204776-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204776-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204776-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204776-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204776-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204776-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204776-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204776-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204776-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	400 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
408b30d6-f5c2-4239-b993-d8f77a8e160b	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	Strength	SPL version
42571-145-05	CELECOXIB	500 in 1 BOTTLE	CAPSULE	500		16
42571-145-60	CELECOXIB	60 in 1 BOTTLE	CAPSULE	60		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-145-60	EA - Each	42571-145	af924375-b6a3-4038-9718-f8a80ef6bd9e	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-145	CELECOXIB (CELECOXIB) CAPSULE [MICRO LABS LIMITED]	16	Current NDC, Legacy NDC, 2 package rows	20250515_408b30d6-f5c2-4239-b993-d8f77a8e160b.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELECOXIB	CELECOXIB	American Health Packaging	4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc7	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	dabfb290-0a7f-3429-e053-2a95a90ae04c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	dac05189-4acf-d6bb-e053-2a95a90a46a9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	Micro Labs Limited	408b30d6-f5c2-4239-b993-d8f77a8e160b	2025-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776 ndc (product): 42571-145
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	550c828b-8c88-4c47-a7b8-a436aed46dc7	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	deeecba5-7a76-444b-a891-b00b1fb16d51	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af9da1f2-717b-32b6-e053-2995a90ae585	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	Proficient Rx LP	1071fcb5-0e9f-4e30-8fb4-df76fd876fe8	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	627abea5-e39a-4e4f-b1ab-4842ed8112e9	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	A-S Medication Solutions	00e67d5e-df6f-4dfd-8c2d-a001c8a99af0	2023-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776
CELECOXIB	CELECOXIB	A-S Medication Solutions	c7a183dc-f4d5-483f-964c-f2745a3640ad	2023-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204776 application number: ANDA204776

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	408b30d6-f5c2-4239-b993-d8f77a8e160b	16
205323	celecoxib 200 MG Oral Capsule	PSN	408b30d6-f5c2-4239-b993-d8f77a8e160b	16
349514	celecoxib 400 MG Oral Capsule	PSN	408b30d6-f5c2-4239-b993-d8f77a8e160b	16
686379	celecoxib 50 MG Oral Capsule	PSN	408b30d6-f5c2-4239-b993-d8f77a8e160b	16
205322	celecoxib 100 MG Oral Capsule	SCD	408b30d6-f5c2-4239-b993-d8f77a8e160b	16
205323	celecoxib 200 MG Oral Capsule	SCD	408b30d6-f5c2-4239-b993-d8f77a8e160b	16
349514	celecoxib 400 MG Oral Capsule	SCD	408b30d6-f5c2-4239-b993-d8f77a8e160b	16
686379	celecoxib 50 MG Oral Capsule	SCD	408b30d6-f5c2-4239-b993-d8f77a8e160b	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-145-05	42571014505	500 CAPSULE in 1 BOTTLE (42571-145-05)	500 capsule	2018-06-01	0000-00-00	No	No	Current
42571-145-60	42571014560	60 CAPSULE in 1 BOTTLE (42571-145-60)	60 capsule	2018-06-01	0000-00-00	No	No	Current