NDC 33261-019-10 - CELEBREX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 33261-019
Requested NDC: 33261-019-10
Package NDCs from labels: 33261-019-10, 33261-019-34, 33261-019-30, 33261-019-60
Manufacturer: Aidarex Pharmaceuticals LLC
Effective date: 2012-09-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
CELEBREX - Aidarex Pharmaceuticals LLC	Aidarex Pharmaceuticals LLC	2012-09-12	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-019-30	2020-01-31	C162847	48780-1	9d75b9cf-d805-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules Initial U.S. Approval: 1998
33261-019-34	2020-01-31	C162847	48780-1	9d75b9cf-d805-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules Initial U.S. Approval: 1998
33261-019-60	2020-01-31	C162847	48780-1	9d75b9cf-d805-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-019-10	CELEBREX	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	1
33261-019-30	CELEBREX	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	1
33261-019-34	CELEBREX	10 in 1 CARTON	CAPSULE	10	1
33261-019-60	CELEBREX	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-019	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20120913_814511c9-89ef-42d7-912e-c00147833b7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-019-10	EA - Each	33261-019	2d59dde0-26e3-486c-a6e0-14d42fb4bc5b	1	2015-10-02
33261-019-30	EA - Each	33261-019	37d175b5-dd8d-4196-95f9-512e3419bf00	1	2015-10-02
33261-019-60	EA - Each	33261-019	8e8ccf32-0c3c-45df-b10f-4f9ef51c35ab	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

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 8 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0d89c39e-4858-4255-9127-1366e005203c	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0dc9020d-28f5-4c69-896c-87b38e3ddb88	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: JCX84Q7J1L
Celecoxib	CELECOXIB	Aurobindo Pharma Limited	1e811c3a-5653-4617-b958-380802cc443a	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	Cadila Pharmaceuticals Limited	78ce3df5-07ee-43bb-9348-104a9524a032	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	Westminster Pharmaceuticals, LLC	cb0be640-067e-4422-9bec-d5fa07175bd0	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
ELYXYB - celecoxib	CELECOXIB	SCILEX PHARMACEUTICALS INC.	c8a5de07-9f27-4a54-a885-8089f0307bd7	2024-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: JCX84Q7J1L
CELEBREX	CELECOXIB	Viatris Specialty LLC	2d6675e4-5859-4be2-8037-a20ce9f707aa	2024-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA020998 rxcui: 213469 rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	Bryant Ranch Prepack	1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6	2024-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	Bryant Ranch Prepack	8a1e9a52-4627-4098-8a11-25e92ad96023	2024-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Clear Eyes Triple Relief	POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	1269a1a6-843d-4d08-bb3c-c1f3d2e7080d	2024-10-25	Warnings	Exact identifier unii: FZ989GH94E
Household Antigens	ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR	Energique, Inc.	87c92497-8a51-4977-87fe-e0b4c6bafb19	2024-09-27	Warnings	Exact identifier unii: 368GB5141J
Celecoxib	CELECOXIB	A-S Medication Solutions	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
CELECOXIB	CELECOXIB	Proficient Rx LP	1071fcb5-0e9f-4e30-8fb4-df76fd876fe8	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: JCX84Q7J1L
Celecoxib	CELECOXIB	A-S Medication Solutions	85b87dd2-c609-4d69-99eb-0acd852acdaf	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	627abea5-e39a-4e4f-b1ab-4842ed8112e9	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	NuCare Pharmaceuticals,Inc.	dfdc74e8-1e4e-53e1-e053-2995a90abc52	2024-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	NuCare Pharmaceuticals, Inc.	1cbe21c0-3425-9a25-e063-6294a90a0d1d	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	NuCare Pharmaceuticals,Inc.	9c1c4911-908e-3c3c-e053-2995a90abcfc	2024-06-14	Warnings	Exact identifier unii: FZ989GH94E
celecoxib	CELECOXIB	NuCare Pharmaceuticals,Inc.	69aebbab-9906-be86-e053-2991aa0aa8a5	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L
Celecoxib	CELECOXIB	Asclemed USA, Inc.	265b50cc-6d99-4ef8-8439-6792e1f21c68	2024-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205323 unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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