FDA.reportPublic FDA data

Celecoxib

Product NDC
71626-303
11-digit product format
716260303
Labeler code
71626
Product ID
71626-303_e35d066f-5127-47f6-8969-221e39c22c01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Medstone Pharma LLC
Application
ANDA210071
Marketing category
ANDA
Marketing start
2018-07-15
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
2020-12-31
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
71626-303-012021-01-29C16284748780-1ba0f9c33-5ade-a910-e053-dadaa90a0b85These 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
71626-303-052021-01-29C16284748780-1ba0f9c33-5ade-a910-e053-dadaa90a0b85These 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
71626-303-302021-01-29C16284748780-1ba0f9c33-5ade-a910-e053-dadaa90a0b85These 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
71626-303-01Celecoxib100 in 1 BOTTLECAPSULE1002
71626-303-05Celecoxib500 in 1 BOTTLECAPSULE5002
71626-303-30Celecoxib30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71626-303-01EA - Each71626-303018dedea-bb74-4765-95c5-eae327e9fce412019-05-02
71626-303-05EA - Each71626-30329f4c9af-78d9-4bd3-9a76-78a0988accef12019-05-02
71626-303-30EA - Each71626-303c9bd495a-13dc-44dd-aac7-ed00bd8eff3412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71626-303CELECOXIB CAPSULE [MEDSTONE PHARMA LLC]2Legacy NDC, 3 package rows20190910_74d4f88e-2bd8-4951-815c-44435380833b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN74d4f88e-2bd8-4951-815c-44435380833b2
205323celecoxib 200 MG Oral CapsulePSN74d4f88e-2bd8-4951-815c-44435380833b2
686379celecoxib 50 MG Oral CapsulePSN74d4f88e-2bd8-4951-815c-44435380833b2
205322celecoxib 100 MG Oral CapsuleSCD74d4f88e-2bd8-4951-815c-44435380833b2
205323celecoxib 200 MG Oral CapsuleSCD74d4f88e-2bd8-4951-815c-44435380833b2
686379celecoxib 50 MG Oral CapsuleSCD74d4f88e-2bd8-4951-815c-44435380833b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71626-303-0171626030301100 in 1 BOTTLEHistorical
71626-303-0571626030305500 in 1 BOTTLEHistorical
71626-303-307162603033030 in 1 BOTTLEHistorical