FDA.reportPublic FDA data

Celecoxib

Product NDC
61919-837
11-digit product format
619190837
Labeler code
61919
Product ID
61919-837_a874b9ae-f62d-5363-e053-2a95a90ab941
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204590
Marketing category
ANDA
Marketing start
2019-07-25
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
2021-12-31
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
61919-837-102025-01-30C16284748780-12cef2736-9d60-d83d-e063-dadaa90ab31fCelecoxib
61919-837-302025-01-30C16284748780-12cef2736-a1df-d83d-e063-dadaa90ab31fCelecoxib
61919-837-422025-01-30C16284748780-12cef2736-a1df-d83d-e063-dadaa90ab31fCelecoxib
61919-837-602025-01-30C16284748780-12cef2736-89a4-d83d-e063-dadaa90ab31fCelecoxib
61919-837-902025-01-30C16284748780-12cef2736-a1df-d83d-e063-dadaa90ab31fCelecoxib

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-837-30Celecoxib30 in 1 BOTTLECAPSULE304
61919-837-42Celecoxib42 in 1 BOTTLECAPSULE424
61919-837-90Celecoxib90 in 1 BOTTLECAPSULE904
61919-837-10Celecoxib10 in 1 BOTTLECAPSULE101
61919-837-60Celecoxib60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-837-10EA - Each61919-837631f791d-87fc-4a43-b98b-6553c0c6c84212019-08-06
61919-837-30EA - Each61919-8376ff326ca-20cd-40c5-b852-3f290c65343412019-08-06
61919-837-42EA - Each61919-8370ddab195-5095-4ef8-a15a-0095e262efb312020-07-13
61919-837-60EA - Each61919-8376e132514-517a-4011-b88d-c449627a28ab12019-07-02
61919-837-90EA - Each61919-837176dcc8d-5c7b-4ddd-bb01-98a73e9cc70012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-837CELECOXIB CAPSULE [DIRECT_RX]4Legacy NDC, 3 package rows20230524_8e86bdbd-2b1f-774e-e053-2995a90a9c4b.zip
61919-837CELECOXIB CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190731_8e87600d-bd9d-4861-e053-2995a90a3260.zip
61919-837CELECOXIB CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190625_8c175caf-cd48-071f-e053-2995a90aac48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN8e86bdbd-2b1f-774e-e053-2995a90a9c4b4
205323celecoxib 200 MG Oral CapsuleSCD8e86bdbd-2b1f-774e-e053-2995a90a9c4b4
205323celecoxib 200 MG Oral CapsulePSN8c175caf-cd48-071f-e053-2995a90aac481
205323celecoxib 200 MG Oral CapsulePSN8e87600d-bd9d-4861-e053-2995a90a32601
205323celecoxib 200 MG Oral CapsuleSCD8c175caf-cd48-071f-e053-2995a90aac481
205323celecoxib 200 MG Oral CapsuleSCD8e87600d-bd9d-4861-e053-2995a90a32601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-837-106191908371010 CAPSULE in 1 BOTTLE (61919-837-10) 10 capsule2019-07-250000-00-00NoNoCurrent
61919-837-306191908373030 CAPSULE in 1 BOTTLE (61919-837-30) 30 capsule2019-07-250000-00-00NoNoCurrent
61919-837-426191908374242 CAPSULE in 1 BOTTLE (61919-837-42) 42 capsule2019-07-250000-00-00NoNoCurrent
61919-837-606191908376060 CAPSULE in 1 BOTTLE (61919-837-60) 60 capsule2019-06-240000-00-00NoNoCurrent
61919-837-906191908379090 CAPSULE in 1 BOTTLE (61919-837-90) 90 capsule2019-07-250000-00-00NoNoCurrent