CELECOXIB

Product NDC: 51655-060
Requested package NDC: 51655-060-52
11-digit product format: 516550060
Labeler code: 51655
Product ID: 51655-060_499c36a6-dd82-e780-e063-6294a90adbee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CELECOXIB
Dosage form: CAPSULE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA207446
Marketing category: ANDA
Marketing start: 2022-09-07
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: 2027-12-31
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
A207446-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23
A207446-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23
A207446-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23
A207446-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207446-001	AB
A207446-002	AB
A207446-003	AB
A207446-004	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	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207446-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-09-23	`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	A207446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207446-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207446-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207446-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207446-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207446-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207446-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207446-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207446-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207446-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207446-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207446-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELECOXIB	CELECOXIB	REMEDYREPACK INC.	27f17ae7-939b-402e-9498-3b6611104089	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	f874eddf-b2f3-6830-e053-6394a90ade7a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	f2a0db9f-174b-1603-e053-2995a90a79a3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446 ndc (package): 51655-060-52 ndc (product): 51655-060 ndc11 (package): 51655006052
CELECOXIB	CELECOXIB	A-S Medication Solutions	95b2ced1-eca2-4c25-aa10-c9fb86b353a3	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	A-S Medication Solutions	7b8e923c-253f-461e-94d7-669e75dc73e9	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	3191c9dc-bfdf-0591-e054-00144ff8d46c	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Quallent Pharmaceuticals Health LLC	aaa3a4f5-b281-415f-a08c-e0cefdae2fb5	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Cipla USA Inc.	d12625b1-2af9-4532-af91-d40b65eeffef	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	NorthStar RxLLC	ce61a585-5ac0-4185-99eb-a9511cd25a98	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af9d962a-5469-2039-e053-2a95a90ad59f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c1abc73e-c6ab-a0a5-e053-2a95a90a0817	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446
CELECOXIB	CELECOXIB	Proficient Rx LP	c91e5933-1798-4096-9f08-fb1200e154e1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207446 application number: ANDA207446

Additional Listing Data#

Finished product: Yes
Brand name base: CELECOXIB
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205323	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
f2a0db9f-174b-1603-e053-2995a90a79a3	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
51655-060-25	CELECOXIB	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	4
51655-060-26	CELECOXIB	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	4
51655-060-52	CELECOXIB	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-060	CELECOXIB CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, 3 package rows	20230306_f2a0db9f-174b-1603-e053-2995a90a79a3.zip

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	f2a0db9f-174b-1603-e053-2995a90a79a3	4
205323	celecoxib 200 MG Oral Capsule	SCD	f2a0db9f-174b-1603-e053-2995a90a79a3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-060-52	51655006052	30 CAPSULE in 1 BOTTLE, PLASTIC (51655-060-52)	30 capsule	2022-09-07	No	No	Current