FDA.reportPublic FDA data

celecoxib

Product NDC
50090-3183
11-digit product format
500903183
Labeler code
50090
Product ID
50090-3183_425da36d-4bb8-4e1b-8957-e6c5aac5776a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207677
Marketing category
ANDA
Marketing start
2015-12-23
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
2022-12-31
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
50090-3183-02023-01-30C16284748780-1f386c64a-30c8-0266-e053-dadaa90a7c1aThese 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
50090-3183-12023-01-30C16284748780-1f386c64a-30c8-0266-e053-dadaa90a7c1aThese 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
50090-3183-22023-01-30C16284748780-1f386c64a-30c8-0266-e053-dadaa90a7c1aThese 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
50090-3183-0celecoxib30 in 1 BOTTLECAPSULE306
50090-3183-1celecoxib60 in 1 BOTTLECAPSULE606
50090-3183-2celecoxib90 in 1 BOTTLE, PLASTICCAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3183-0EA - Each50090-3183fee8bc74-debb-471f-8ed0-3eb94c5bb51e12019-05-02
50090-3183-1EA - Each50090-31835827c28b-6c21-4fd1-8dbd-4518dee34f2a12019-05-02
50090-3183-2EA - Each50090-318378ca1e9d-9ced-452d-8c01-0622e8574a1e12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3183CELECOXIB CAPSULE [A-S MEDICATION SOLUTIONS]6Legacy NDC, 3 package rows20210417_6984bd91-8fb8-4894-bcd1-09e528d4251f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN6984bd91-8fb8-4894-bcd1-09e528d4251f6
205323celecoxib 200 MG Oral CapsuleSCD6984bd91-8fb8-4894-bcd1-09e528d4251f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3183-05009031830030 CAPSULE in 1 BOTTLE (50090-3183-0) 30 capsule2017-10-230000-00-00NoNoCurrent
50090-3183-15009031830160 CAPSULE in 1 BOTTLE (50090-3183-1) 60 capsule2018-12-110000-00-00NoNoCurrent
50090-3183-25009031830290 CAPSULE in 1 BOTTLE, PLASTIC (50090-3183-2) 90 capsule2015-12-230000-00-00NoNoCurrent