FDA.reportPublic FDA data

Celecoxib

Product NDC
68071-2776
11-digit product format
680712776
Labeler code
68071
Product ID
68071-2776_e2ad4228-9de2-5b5c-e053-2995a90ad6a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205129
Marketing category
ANDA
Marketing start
2020-12-03
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
68071-2776-22025-01-30C16284748780-12cef2736-8199-d83d-e063-dadaa90ab31fThese 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
68071-2776-32025-01-30C16284748780-12cef2736-8199-d83d-e063-dadaa90ab31fThese 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
68071-2776-2Celecoxib22 in 1 BOTTLECAPSULE222
68071-2776-3Celecoxib30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2776CELECOXIB CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20231207_e2ad2dae-311d-7b9c-e053-2995a90aa380.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNe2ad2dae-311d-7b9c-e053-2995a90aa3802
205322celecoxib 100 MG Oral CapsuleSCDe2ad2dae-311d-7b9c-e053-2995a90aa3802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2776-26807127760222 in 1 BOTTLEHistorical
68071-2776-36807127760330 CAPSULE in 1 BOTTLE (68071-2776-3) 30 capsule2022-06-300000-00-00NoNoCurrent