Ibuprofen

Product NDC
42254-063
11-digit product format
422540063
Labeler code
42254
Product ID
42254-063_940f3140-fe00-4297-ba81-f49bc3a3ace0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 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
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-063-30Ibuprofen30 in 1 BOTTLETABLET301
42254-063-40Ibuprofen40 in 1 BOTTLETABLET401
42254-063-60Ibuprofen60 in 1 BOTTLETABLET601
42254-063-90Ibuprofen90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-063IBUPROFEN TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20120316_940f3140-fe00-4297-ba81-f49bc3a3ace0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN940f3140-fe00-4297-ba81-f49bc3a3ace01
197806ibuprofen 600 MG Oral TabletPSN940f3140-fe00-4297-ba81-f49bc3a3ace01
197807ibuprofen 800 MG Oral TabletPSN940f3140-fe00-4297-ba81-f49bc3a3ace01
197805ibuprofen 400 MG Oral TabletSCD940f3140-fe00-4297-ba81-f49bc3a3ace01
197806ibuprofen 600 MG Oral TabletSCD940f3140-fe00-4297-ba81-f49bc3a3ace01
197807ibuprofen 800 MG Oral TabletSCD940f3140-fe00-4297-ba81-f49bc3a3ace01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-063-304225400633030 in 1 BOTTLEHistorical
42254-063-404225400634040 in 1 BOTTLEHistorical
42254-063-604225400636060 in 1 BOTTLEHistorical
42254-063-904225400639090 in 1 BOTTLEHistorical