FDA.reportPublic FDA data

CELEBREX

Product NDC
52959-539
11-digit product format
529590539
Labeler code
52959
Product ID
52959-539_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
200 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
52959-539-002019-11-13C16284748780-197449f38-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
52959-539-052019-11-13C16284748780-197449f38-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
52959-539-072019-11-13C16284748780-197449f38-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
52959-539-102019-11-13C16284748780-197449f38-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
52959-539-142019-11-13C16284748780-197449f38-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
52959-539-152019-11-13C16284748780-197449f38-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
52959-539-202019-11-13C16284748780-197449f38-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
52959-539-212019-11-13C16284748780-197449f38-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
52959-539-282019-11-13C16284748780-197449f38-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
52959-539-302019-11-13C16284748780-197449f38-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
52959-539-402019-11-13C16284748780-197449f38-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
52959-539-452019-11-13C16284748780-197449f38-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
52959-539-00CELEBREX100 in 1 BOTTLECAPSULE1003
52959-539-05CELEBREX5 in 1 BOTTLECAPSULE53
52959-539-07CELEBREX7 in 1 BOTTLECAPSULE73
52959-539-10CELEBREX10 in 1 BOTTLECAPSULE103
52959-539-14CELEBREX14 in 1 BOTTLECAPSULE143
52959-539-15CELEBREX15 in 1 BOTTLECAPSULE153
52959-539-20CELEBREX20 in 1 BOTTLECAPSULE203
52959-539-21CELEBREX21 in 1 BOTTLECAPSULE213
52959-539-28CELEBREX28 in 1 BOTTLECAPSULE283
52959-539-30CELEBREX30 in 1 BOTTLECAPSULE303
52959-539-40CELEBREX40 in 1 BOTTLECAPSULE403
52959-539-45CELEBREX45 in 1 BOTTLECAPSULE453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-539-00EA - Each52959-5390fb54a30-8c0b-479c-b23b-d20ba59f445012012-07-24
52959-539-05EA - Each52959-5390cedd477-a113-426d-b08c-dba18bf1677a12012-07-24
52959-539-07EA - Each52959-5392924e45d-3c22-46c2-93a2-9b31ffabe90912012-07-24
52959-539-10EA - Each52959-539d75a7114-fd24-4709-890d-ac3a5054794612012-07-24
52959-539-14EA - Each52959-5394347b70e-3fd9-480e-a4dc-ef3a2ae4b0e512012-07-24
52959-539-15EA - Each52959-5395de7246b-9d56-4294-83af-2ada8e218b0612012-07-24
52959-539-20EA - Each52959-53959eab195-45ba-4892-b95b-e81dea480b7812012-07-24
52959-539-21EA - Each52959-539fffda792-18ff-470c-aeb6-d0481c2fe9d812012-07-24
52959-539-28EA - Each52959-53964a8a6ad-41be-4bab-8df9-424541bee65b12012-07-24
52959-539-30EA - Each52959-539e84eaf7b-51ec-4744-87d1-0a3393cc878c12012-07-24
52959-539-40EA - Each52959-5393b2de36b-c307-4942-a167-09fd7f517af212012-07-24
52959-539-45EA - Each52959-5398b7d24e6-0730-4777-8e8b-c801c5b2ec2f12012-07-24

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
52959-539CELEBREX (CELECOXIB) CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 12 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
52959-539-0052959053900100 in 1 BOTTLEHistorical
52959-539-05529590539055 in 1 BOTTLEHistorical
52959-539-07529590539077 in 1 BOTTLEHistorical
52959-539-105295905391010 in 1 BOTTLEHistorical
52959-539-145295905391414 in 1 BOTTLEHistorical
52959-539-155295905391515 in 1 BOTTLEHistorical
52959-539-205295905392020 in 1 BOTTLEHistorical
52959-539-215295905392121 in 1 BOTTLEHistorical
52959-539-285295905392828 in 1 BOTTLEHistorical
52959-539-305295905393030 in 1 BOTTLEHistorical
52959-539-405295905394040 in 1 BOTTLEHistorical
52959-539-455295905394545 in 1 BOTTLEHistorical