CELECOXIB

Product NDC
61919-682
11-digit product format
619190682
Labeler code
61919
Product ID
61919-682_d357e6da-7824-1903-e053-2995a90a3c72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204590
Marketing category
ANDA
Marketing start
2021-11-19
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
61919-682-302025-01-30C16284748780-12cef2736-8abb-d83d-e063-dadaa90ab31fCELECOXIB
61919-682-602025-01-30C16284748780-12cef2736-8abb-d83d-e063-dadaa90ab31fCELECOXIB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-682-30CELECOXIB30 in 1 BOTTLECAPSULE309
61919-682-60CELECOXIB60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-682-30EA - Each61919-682eec25a40-5704-49aa-848b-c8d1fd17dcf412019-04-11
61919-682-60EA - Each61919-682c7926ccb-9690-4028-b4e9-4f9afcc6a48312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-682CELECOXIB CAPSULE [DIRECT_RX]9Legacy NDC, 2 package rows20230419_2e1b6011-d3c7-63a0-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN2e1b6011-d3c7-63a0-e054-00144ff88e889
205323celecoxib 200 MG Oral CapsulePSN2e1b6011-d3c7-63a0-e054-00144ff88e889
205322celecoxib 100 MG Oral CapsuleSCD2e1b6011-d3c7-63a0-e054-00144ff88e889
205323celecoxib 200 MG Oral CapsuleSCD2e1b6011-d3c7-63a0-e054-00144ff88e889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-682-306191906823030 CAPSULE in 1 BOTTLE (61919-682-30) 30 capsule2019-09-180000-00-00NoNoCurrent
61919-682-606191906826060 CAPSULE in 1 BOTTLE (61919-682-60) 60 capsule2021-11-190000-00-00NoNoCurrent