FDA.reportPublic FDA data

CELECOXIB

Product NDC
61919-360
11-digit product format
619190360
Labeler code
61919
Product ID
61919-360_d357e6da-7824-1903-e053-2995a90a3c72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204197
Marketing category
ANDA
Marketing start
2016-03-02
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
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
61919-360-102025-01-30C16284748780-12cef2736-8abb-d83d-e063-dadaa90ab31fCELECOXIB
61919-360-152025-01-30C16284748780-12cef2736-8abb-d83d-e063-dadaa90ab31fCELECOXIB
61919-360-422025-01-30C16284748780-12cef2736-932b-d83d-e063-dadaa90ab31fCELECOXIB 200mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-360-10CELECOXIB10 in 1 BOTTLECAPSULE109
61919-360-15CELECOXIB15 in 1 BOTTLECAPSULE159
61919-360-42CELECOXIB42 in 1 BOTTLECAPSULE421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-360-10EA - Each61919-3609fb0488b-29d1-46d0-af70-8828d1609e0d12016-09-02
61919-360-15EA - Each61919-360d6ffa0f2-4f18-420b-bf19-653e4e10971a12019-08-06
61919-360-42EA - Each61919-3600f7a312d-75d3-46c0-bc3a-d1b7725c04e612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-360CELECOXIB CAPSULE [DIRECT_RX]9Legacy NDC, 2 package rows20230419_2e1b6011-d3c7-63a0-e054-00144ff88e88.zip
61919-360CELECOXIB CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190726_8e859901-e41c-420b-e053-2995a90ae09a.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
205323celecoxib 200 MG Oral CapsulePSN8e859901-e41c-420b-e053-2995a90ae09a1
205323celecoxib 200 MG Oral CapsuleSCD8e859901-e41c-420b-e053-2995a90ae09a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-360-106191903601010 CAPSULE in 1 BOTTLE (61919-360-10) 10 capsule2016-03-020000-00-00NoNoCurrent
61919-360-156191903601515 CAPSULE in 1 BOTTLE (61919-360-15) 15 capsule2016-03-020000-00-00NoNoCurrent
61919-360-426191903604242 CAPSULE in 1 BOTTLE (61919-360-42) 42 capsule2019-07-250000-00-00NoNoCurrent