CELECOXIB

Product NDC
76282-693
11-digit product format
762820693
Labeler code
76282
Product ID
76282-693_3c87c0ca-ac6b-40bf-8532-2f995faeceda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc
Application
ANDA207446
Marketing category
ANDA
Marketing start
2020-12-28
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-693-01CELECOXIB100 in 1 BOTTLECAPSULE1001
76282-693-05CELECOXIB500 in 1 BOTTLECAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-693CELECOXIB CAPSULE [EXELAN PHARMACEUTICALS, INC]1Legacy NDC, 2 package rows20201228_c96b34d6-52b5-4bd6-b7d0-93bf6380ef08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
205323celecoxib 200 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
349514celecoxib 400 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
686379celecoxib 50 MG Oral CapsulePSNc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
205322celecoxib 100 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
205323celecoxib 200 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
349514celecoxib 400 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081
686379celecoxib 50 MG Oral CapsuleSCDc96b34d6-52b5-4bd6-b7d0-93bf6380ef081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-693-0176282069301100 CAPSULE in 1 BOTTLE (76282-693-01) 100 capsule2020-12-280000-00-00NoNoCurrent
76282-693-0576282069305500 CAPSULE in 1 BOTTLE (76282-693-05) 500 capsule2020-12-280000-00-00NoNoCurrent