FDA.reportPublic FDA data

Celecoxib

Product NDC
50436-3849
11-digit product format
504363849
Labeler code
50436
Product ID
50436-3849_d165d1f4-c436-4f7c-a706-5fdd5a4a02a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
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],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
50436-3849-12021-01-29C16284748780-1ba0f9c33-40fe-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
50436-3849-22021-01-29C16284748780-1ba0f9c33-40fe-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
50436-3849-1Celecoxib30 in 1 BOTTLECAPSULE302
50436-3849-2Celecoxib60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3849-1EA - Each50436-3849cf0693e6-12c1-4f95-ac6d-5e0416a96d3912017-09-11
50436-3849-2EA - Each50436-3849a2970cc0-0cbb-410a-b387-1f97e2935b1a12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3849CELECOXIB CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20170824_a76b143e-70c7-41da-b40b-adee661f0a60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNa76b143e-70c7-41da-b40b-adee661f0a602
205323celecoxib 200 MG Oral CapsuleSCDa76b143e-70c7-41da-b40b-adee661f0a602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3849-15043638490130 in 1 BOTTLEHistorical
50436-3849-25043638490260 in 1 BOTTLEHistorical