FDA.reportPublic FDA data

CELECOXIB

Product NDC
50436-0144
11-digit product format
504360144
Labeler code
50436
Product ID
50436-0144_3e7beb93-c02d-4ce4-b880-16eed22e582f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
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
2022-12-31
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
50436-0144-12023-01-30C16284748780-1f386c64a-4752-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50436-0144-22023-01-30C16284748780-1f386c64a-4752-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CELECOXIB CAPSULE safely and effectively. See full prescribing information for CELECOXIB CAPSULE. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0144-1CELECOXIB30 in 1 BOTTLECAPSULE302
50436-0144-2CELECOXIB60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0144-1EA - Each50436-0144a75f5212-6d52-40db-a281-712c2079e5ca12021-12-08
50436-0144-2EA - Each50436-014488d4d49d-357c-4ac0-b5c7-b69f6a30a67b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0144CELECOXIB (CELECOXIB) CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20211201_67c6ea14-efbb-40b0-ab53-fddaa30204c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN67c6ea14-efbb-40b0-ab53-fddaa30204c62
205323celecoxib 200 MG Oral CapsuleSCD67c6ea14-efbb-40b0-ab53-fddaa30204c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0144-15043601440130 CAPSULE in 1 BOTTLE (50436-0144-1) 30 capsule2021-10-250000-00-00NoNoCurrent
50436-0144-25043601440260 CAPSULE in 1 BOTTLE (50436-0144-2) 60 capsule2021-10-250000-00-00NoNoCurrent