FDA.reportPublic FDA data

Celecoxib

Product NDC
69677-154
11-digit product format
696770154
Labeler code
69677
Product ID
69677-154_56d1e6f1-7b5a-3d73-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Mas Management Group, Inc.
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-03
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
69677-154-012020-01-31C16284748780-19d75b9d1-106b-f424-e053-dadaa90a57ceThese 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
69677-154-152020-01-31C16284748780-19d75b9d1-106b-f424-e053-dadaa90a57ceThese 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
69677-154-302020-01-31C16284748780-19d75b9d1-106b-f424-e053-dadaa90a57ceThese 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
69677-154-602020-01-31C16284748780-19d75b9d1-106b-f424-e053-dadaa90a57ceThese 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
69677-154-902020-01-31C16284748780-19d75b9d1-106b-f424-e053-dadaa90a57ceThese 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
69677-154-01Celecoxib120 in 1 BOTTLECAPSULE1201
69677-154-15Celecoxib15 in 1 BOTTLECAPSULE151
69677-154-30Celecoxib30 in 1 BOTTLECAPSULE301
69677-154-60Celecoxib60 in 1 BOTTLECAPSULE601
69677-154-90Celecoxib90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69677-154-01EA - Each69677-15487ccf1ed-5d4c-4130-b96a-268df8be946c12017-10-13
69677-154-15EA - Each69677-15423d8db3f-6424-4ab6-a7ff-dfda4d6321a412017-10-13
69677-154-30EA - Each69677-154276eae42-b75e-4ad5-aa43-41910c8c233d12017-10-13
69677-154-60EA - Each69677-15469f61d33-b82f-4519-825d-ba97e850dea512017-10-13
69677-154-90EA - Each69677-154d861e4b9-7831-4574-8565-105f57bd57f512017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69677-154CELECOXIB CAPSULE [MAS MANAGEMENT GROUP, INC.]1Legacy NDC, 5 package rows20170818_56d1e6f1-7b59-3d73-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN56d1e6f1-7b59-3d73-e054-00144ff8d46c1
205323celecoxib 200 MG Oral CapsuleSCD56d1e6f1-7b59-3d73-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69677-154-0169677015401120 in 1 BOTTLEHistorical
69677-154-156967701541515 in 1 BOTTLEHistorical
69677-154-306967701543030 in 1 BOTTLEHistorical
69677-154-606967701546060 in 1 BOTTLEHistorical
69677-154-906967701549090 in 1 BOTTLEHistorical