FDA.reportPublic FDA data

CELEBREX

Product NDC
33261-019
11-digit product format
332610019
Labeler code
33261
Product ID
33261-019_bcb89362-3e1a-41ed-ba17-d740662897e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213469CeleBREX 200 MG Oral CapsulePSN814511c9-89ef-42d7-912e-c00147833b7e1
205323celecoxib 200 MG Oral CapsulePSN814511c9-89ef-42d7-912e-c00147833b7e1
213469celecoxib 200 MG Oral Capsule [Celebrex]SBD814511c9-89ef-42d7-912e-c00147833b7e1
205323celecoxib 200 MG Oral CapsuleSCD814511c9-89ef-42d7-912e-c00147833b7e1
213469Celebrex 200 MG Oral CapsuleSY814511c9-89ef-42d7-912e-c00147833b7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-019-103326100191010 in 1 BOTTLE, PLASTICHistorical
33261-019-303326100193030 in 1 BOTTLE, PLASTICHistorical
33261-019-343326100193410 in 1 CARTONHistorical
33261-019-603326100196060 in 1 BOTTLE, PLASTICHistorical