FDA.reportPublic FDA data

CELEBREX

Product NDC
67544-204
11-digit product format
675440204
Labeler code
67544
Product ID
67544-204_a427cdfd-7e1f-4f7c-ba6a-167e56d9d340
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, 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
67544-204-302020-01-31C16284748780-19d75b9cf-ef4e-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
67544-204-30CELEBREX30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-204-30EA - Each67544-20458dcc65b-4f24-439d-b8ba-069a40c7aebf12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-204CELEBREX (CELECOXIB) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 1 package rows20140708_05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213469CeleBREX 200 MG Oral CapsulePSN05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e2
205323celecoxib 200 MG Oral CapsulePSN05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e2
213469celecoxib 200 MG Oral Capsule [Celebrex]SBD05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e2
205323celecoxib 200 MG Oral CapsuleSCD05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e2
213469Celebrex 200 MG Oral CapsuleSY05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-204-306754402043030 in 1 BOTTLE, PLASTICHistorical