FDA.reportPublic FDA data

CELEBREX

Product NDC
52959-540
11-digit product format
529590540
Labeler code
52959
Product ID
52959-540_fa8f4605-2a86-49f2-8a42-d706ce01a5b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
52959-540-142019-11-13C16284748780-197449f38-cad6-f6ea-e053-dbdaa90aa703These 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
52959-540-152019-11-13C16284748780-197449f38-cad6-f6ea-e053-dbdaa90aa703These 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
52959-540-202019-11-13C16284748780-197449f38-cad6-f6ea-e053-dbdaa90aa703These 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
52959-540-212019-11-13C16284748780-197449f38-cad6-f6ea-e053-dbdaa90aa703These 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
52959-540-282019-11-13C16284748780-197449f38-cad6-f6ea-e053-dbdaa90aa703These 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
52959-540-302019-11-13C16284748780-197449f38-cad6-f6ea-e053-dbdaa90aa703These 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
52959-540-402019-11-13C16284748780-197449f38-cad6-f6ea-e053-dbdaa90aa703These 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
52959-540-14CELEBREX14 in 1 BOTTLECAPSULE143
52959-540-15CELEBREX15 in 1 BOTTLECAPSULE153
52959-540-20CELEBREX20 in 1 BOTTLECAPSULE203
52959-540-21CELEBREX21 in 1 BOTTLECAPSULE213
52959-540-28CELEBREX28 in 1 BOTTLECAPSULE283
52959-540-30CELEBREX30 in 1 BOTTLECAPSULE303
52959-540-40CELEBREX40 in 1 BOTTLECAPSULE403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-540-14EA - Each52959-540fbdde64f-e276-498c-91bf-11f87188ea9412012-07-24
52959-540-15EA - Each52959-540e595cc3e-6d1b-45f0-940e-926705d26d4312012-07-24
52959-540-20EA - Each52959-54056da9962-4675-41be-a1f9-ba79703b7f7b12012-07-24
52959-540-21EA - Each52959-5402364d3cd-b43f-475a-a1b8-a99cbab8768612012-07-24
52959-540-28EA - Each52959-540b7e1043c-5acd-4ee4-9e80-c09c6cb565e212012-07-24
52959-540-30EA - Each52959-54082938230-6211-46db-a5d7-cc9078dd4c2f12012-07-24
52959-540-40EA - Each52959-540f1ac37b6-2a2a-4529-bf75-8253a3cb1c8412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CelecoxibACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3
CelecoxibACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3
gelatinINACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3
povidoneINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-540CELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 7 package rows20111215_b6bd0101-ebf0-43e8-99bf-21cb032b05d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213468CeleBREX 100 MG Oral CapsulePSNb6bd0101-ebf0-43e8-99bf-21cb032b05d63
213469CeleBREX 200 MG Oral CapsulePSNb6bd0101-ebf0-43e8-99bf-21cb032b05d63
205322celecoxib 100 MG Oral CapsulePSNb6bd0101-ebf0-43e8-99bf-21cb032b05d63
205323celecoxib 200 MG Oral CapsulePSNb6bd0101-ebf0-43e8-99bf-21cb032b05d63
213468celecoxib 100 MG Oral Capsule [Celebrex]SBDb6bd0101-ebf0-43e8-99bf-21cb032b05d63
213469celecoxib 200 MG Oral Capsule [Celebrex]SBDb6bd0101-ebf0-43e8-99bf-21cb032b05d63
205322celecoxib 100 MG Oral CapsuleSCDb6bd0101-ebf0-43e8-99bf-21cb032b05d63
205323celecoxib 200 MG Oral CapsuleSCDb6bd0101-ebf0-43e8-99bf-21cb032b05d63
213468Celebrex 100 MG Oral CapsuleSYb6bd0101-ebf0-43e8-99bf-21cb032b05d63
213469Celebrex 200 MG Oral CapsuleSYb6bd0101-ebf0-43e8-99bf-21cb032b05d63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-540-145295905401414 in 1 BOTTLEHistorical
52959-540-155295905401515 in 1 BOTTLEHistorical
52959-540-205295905402020 in 1 BOTTLEHistorical
52959-540-215295905402121 in 1 BOTTLEHistorical
52959-540-285295905402828 in 1 BOTTLEHistorical
52959-540-305295905403030 in 1 BOTTLEHistorical
52959-540-405295905404040 in 1 BOTTLEHistorical