FDA.reportPublic FDA data

Celecoxib 200 mg

Product NDC
53217-206
11-digit product format
532170206
Labeler code
53217
Product ID
53217-206_a86fe478-7d07-4e35-b76f-dd3d8b81ecc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA204519
Marketing category
ANDA
Marketing start
2015-11-24
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
53217-206-302020-01-31C16284748780-19d75b9d0-28f6-f424-e053-dadaa90a57ceCelecoxib 200 mg These 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
53217-206-602020-01-31C16284748780-19d75b9d0-28f6-f424-e053-dadaa90a57ceCelecoxib 200 mg These 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
53217-206-902020-01-31C16284748780-19d75b9d0-28f6-f424-e053-dadaa90a57ceCelecoxib 200 mg These 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
53217-206-30Celecoxib 200 mg30 in 1 BOTTLECAPSULE303
53217-206-60Celecoxib 200 mg60 in 1 BOTTLECAPSULE603
53217-206-90Celecoxib 200 mg90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-206-30EA - Each53217-206dc65460d-e243-4eef-87d8-0d2f8762604912017-03-06
53217-206-60EA - Each53217-206ab273fe3-9372-4af8-93fd-e914b868a67012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-206CELECOXIB 200 MG (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 3 package rows20170228_292fea0e-55ee-4f08-ad03-991fe2b4dc42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN292fea0e-55ee-4f08-ad03-991fe2b4dc423
205323celecoxib 200 MG Oral CapsuleSCD292fea0e-55ee-4f08-ad03-991fe2b4dc423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-206-305321702063030 in 1 BOTTLEHistorical
53217-206-605321702066060 in 1 BOTTLEHistorical
53217-206-905321702069090 in 1 BOTTLEHistorical