FDA.reportPublic FDA data

CELEBREX

Product NDC
68387-552
11-digit product format
683870552
Labeler code
68387
Product ID
68387-552_8988f2ff-e9e5-47c4-816b-0fc28a599780
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
NDA020998
Marketing category
NDA
Marketing start
2006-03-01
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
68387-552-152019-10-29C16284748780-1960f7f55-c554-8e05-e053-dbdaa90a074aThese 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
68387-552-302019-10-29C16284748780-1960f7f55-c554-8e05-e053-dbdaa90a074aThese 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
68387-552-602019-10-29C16284748780-1960f7f55-c554-8e05-e053-dbdaa90a074aThese 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
68387-552-15CELEBREX15 in 1 BOTTLE, PLASTICCAPSULE151
68387-552-30CELEBREX30 in 1 BOTTLE, PLASTICCAPSULE301
68387-552-60CELEBREX60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-552-15EA - Each68387-552f391c515-541e-4a7f-8857-65a8bfdd483a12012-07-24
68387-552-30EA - Each68387-552c1bc6c14-bc07-4dce-8b1d-fd9db891244f12012-07-24
68387-552-60EA - Each68387-552b2e1b572-c51e-4162-aa4b-d45a5be0713212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
CelecoxibACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-552CELEBREX (CELECOXIB) CAPSULE [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 3 package rows20110712_bff7e0aa-0c01-4f6e-89ed-da27cc36706e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213469CeleBREX 200 MG Oral CapsulePSNbff7e0aa-0c01-4f6e-89ed-da27cc36706e1
205323celecoxib 200 MG Oral CapsulePSNbff7e0aa-0c01-4f6e-89ed-da27cc36706e1
213469celecoxib 200 MG Oral Capsule [Celebrex]SBDbff7e0aa-0c01-4f6e-89ed-da27cc36706e1
205323celecoxib 200 MG Oral CapsuleSCDbff7e0aa-0c01-4f6e-89ed-da27cc36706e1
213469Celebrex 200 MG Oral CapsuleSYbff7e0aa-0c01-4f6e-89ed-da27cc36706e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-552-156838705521515 in 1 BOTTLE, PLASTICHistorical
68387-552-306838705523030 in 1 BOTTLE, PLASTICHistorical
68387-552-606838705526060 in 1 BOTTLE, PLASTICHistorical