FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
CELEBREX - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2012-09-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-019-302020-01-31C16284748780-19d75b9cf-d805-f424-e053-dadaa90a57ceThese 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
33261-019-342020-01-31C16284748780-19d75b9cf-d805-f424-e053-dadaa90a57ceThese 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
33261-019-602020-01-31C16284748780-19d75b9cf-d805-f424-e053-dadaa90a57ceThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
33261-019-10CELEBREX10 in 1 BOTTLE, PLASTICCAPSULE101
33261-019-30CELEBREX30 in 1 BOTTLE, PLASTICCAPSULE301
33261-019-34CELEBREX10 in 1 CARTONCAPSULE101
33261-019-60CELEBREX60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-019CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20120913_814511c9-89ef-42d7-912e-c00147833b7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-019-10EA - Each33261-0192d59dde0-26e3-486c-a6e0-14d42fb4bc5b12015-10-02
33261-019-30EA - Each33261-01937d175b5-dd8d-4196-95f9-512e3419bf0012015-10-02
33261-019-60EA - Each33261-0198e8ccf32-0c3c-45df-b10f-4f9ef51c35ab12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (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 7 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBBryant Ranch Prepacka9749f00-0307-4842-a95b-9a8b4989df252025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepack550c828b-8c88-4c47-a7b8-a436aed46dc72025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepackdeeecba5-7a76-444b-a891-b00b1fb16d512025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBEPIC PHARMA, LLCac670924-0a3f-4f94-ac01-9e3c3071c9902025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBCranbury Pharmaceuticals, LLC933532fa-044a-48b1-bbe4-28062564f98a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf73fea0-5cd1-0fa2-e053-2a95a90af8fc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9d962a-5469-2039-e053-2a95a90ad59f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9da1f2-717b-32b6-e053-2995a90ae5852024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCb3545cfb-97c3-b896-e053-2a95a90a15a02024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc8ade384-2072-2cc2-e053-2a95a90ae7912024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc1abc73e-c6ab-a0a5-e053-2a95a90a08172024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf60394f5-fd69-929b-e053-2995a90a57932024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdcc56-7a53-9a42-e053-6394a90a48d52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdd580-09da-9c1c-e053-6394a90a47062024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBModavar Pharmaceuticals LLCb0f73074-f3d8-4812-8e64-f88a02869ed32024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
celecoxibCELECOXIBTorrent Pharmaceuticals Limited862698b6-2cc9-4374-992d-024beae6eba32024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
CelecoxibCELECOXIBQuality Care Products, LLCfcf49d7f-8319-4051-b7ac-fe063268b39b2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBUnichem Pharmaceuticals (USA), Inc.0e8484a8-04a6-4be3-8c5c-1883b0490d532024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
celecoxibCELECOXIBQuality Care Products LLCf0df546e-17c9-4e85-839d-336612d7b9e52024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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