FDA.reportPublic FDA data

Celecoxib

Product NDC
50436-3983
11-digit product format
504363983
Labeler code
50436
Product ID
50436-3983_a360f53f-e638-445f-9fe2-9bf11baa7c0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA200562
Marketing category
ANDA
Marketing start
2015-03-12
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
50436-3983-12024-01-30C16284748780-1ba0f9c33-5561-a910-e053-dadaa90a0b85These 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
50436-3983-12022-10-17C16284748780-1ba0f9c33-5561-a910-e053-dadaa90a0b85These 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
50436-3983-12021-01-29C16284748780-1ba0f9c33-5561-a910-e053-dadaa90a0b85These 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
50436-3983-1Celecoxib30 in 1 BOTTLECAPSULE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3983-1EA - Each50436-3983f8d50cfb-6f8d-4076-9d5c-161cb8e7e90512017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3983CELECOXIB CAPSULE [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20221018_298dd3a8-2cec-4260-961a-6294d08eecf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN298dd3a8-2cec-4260-961a-6294d08eecf76
205323celecoxib 200 MG Oral CapsulePSN298dd3a8-2cec-4260-961a-6294d08eecf76
205322celecoxib 100 MG Oral CapsuleSCD298dd3a8-2cec-4260-961a-6294d08eecf76
205323celecoxib 200 MG Oral CapsuleSCD298dd3a8-2cec-4260-961a-6294d08eecf76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-3983-15043639830130 CAPSULE in 1 BOTTLE (50436-3983-1) 30 capsule2017-08-040000-00-00NoNoCurrent