FDA.reportPublic FDA data

Celecoxib

Product NDC
50436-7701
11-digit product format
504367701
Labeler code
50436
Product ID
50436-7701_4eb0c01b-f375-4c01-b53e-84c78cf319c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
NDA020998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-12-10
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
2020-12-31
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
50436-7701-12021-01-29C16284748780-1ba0f9c33-186e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib capsules, for oral use Initial U.S. Approval: 1998
50436-7701-22021-01-29C16284748780-1ba0f9c33-186e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-7701-1Celecoxib30 in 1 BOTTLECAPSULE308
50436-7701-2Celecoxib60 in 1 BOTTLECAPSULE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-7701-1EA - Each50436-7701b5143937-1f43-431f-b7dd-16ce92672c5512015-10-02
50436-7701-2EA - Each50436-7701adab57ab-abe2-4475-9ad6-27051415ff2212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [UNIT DOSE SERVICES]2
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [UNIT DOSE SERVICES]2
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [UNIT DOSE SERVICES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [UNIT DOSE SERVICES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7701CELECOXIB CAPSULE [UNIT DOSE SERVICES]8Legacy NDC, 2 package rows20170702_fbe2ac60-fc15-471a-b616-7a378a549f1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNfbe2ac60-fc15-471a-b616-7a378a549f1c8
205323celecoxib 200 MG Oral CapsulePSNfbe2ac60-fc15-471a-b616-7a378a549f1c8
205322celecoxib 100 MG Oral CapsuleSCDfbe2ac60-fc15-471a-b616-7a378a549f1c8
205323celecoxib 200 MG Oral CapsuleSCDfbe2ac60-fc15-471a-b616-7a378a549f1c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7701-15043677010130 in 1 BOTTLEHistorical
50436-7701-25043677010260 in 1 BOTTLEHistorical