FDA.reportPublic FDA data

Celecoxib

Product NDC
70882-129
11-digit product format
708820129
Labeler code
70882
Product ID
70882-129_79f328f1-ce1a-435e-9540-6e14374989d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Cambridge Therapeutics Technologies, LLC
Application
ANDA206827
Marketing category
ANDA
Marketing start
2016-02-01
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
70882-129-142020-01-31C16284748780-19d75b9cf-dbf5-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
70882-129-14Celecoxib14 in 1 BLISTER PACKCAPSULE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70882-129-14EA - Each70882-12969ff7e80-ada2-4846-8166-b87bcb4b332312017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70882-129CELECOXIB CAPSULE [CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC]1Legacy NDC, 1 package rows20170622_03c40e1c-c274-48d9-9c70-5f2a670e49cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN03c40e1c-c274-48d9-9c70-5f2a670e49cc1
205323celecoxib 200 MG Oral CapsuleSCD03c40e1c-c274-48d9-9c70-5f2a670e49cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70882-129-147088201291414 in 1 BLISTER PACKHistorical