FDA.reportPublic FDA data

Celecoxib

Product NDC
33358-902
11-digit product format
333580902
Labeler code
33358
Product ID
33358-902_2ebb850f-d998-06ea-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
RxChange Co.
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-03
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
33358-902-152020-01-31C16284748780-19d75b9d0-b6dd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use INITIAL U.S. APPROVAL: 1998
33358-902-302020-01-31C16284748780-19d75b9d0-b6dd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use INITIAL U.S. APPROVAL: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-902-15Celecoxib15 in 1 BOTTLECAPSULE152
33358-902-30Celecoxib30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-902-15EA - Each33358-902469db3d2-8c1b-44be-9e77-ff98be17df2912016-04-04
33358-902-30EA - Each33358-902cd9f3b22-a2e7-4064-a497-51d0be533f2d12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-902CELECOXIB CAPSULE [RXCHANGE CO.]2Legacy NDC, 2 package rows20160323_4b99169a-3401-4a15-ad8b-319b46d2b98e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN4b99169a-3401-4a15-ad8b-319b46d2b98e2
205323celecoxib 200 MG Oral CapsuleSCD4b99169a-3401-4a15-ad8b-319b46d2b98e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-902-153335809021515 in 1 BOTTLEHistorical
33358-902-303335809023030 in 1 BOTTLEHistorical