FDA.reportPublic FDA data

IBU

Product NDC
50090-4339
11-digit product format
500904339
Labeler code
50090
Product ID
50090-4339_d4ff5681-5670-4f92-b7a0-d7f33a360946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075682
Marketing category
ANDA
Marketing start
2008-11-20
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4339-02023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-12023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-22023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-32023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-42023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-52023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-72023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-82023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4339-92023-01-30C16284748780-1f386c649-a7b3-0266-e053-dadaa90a7c1aIBU ™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4339-0IBU10 in 1 BOTTLETABLET102
50090-4339-1IBU15 in 1 BOTTLETABLET152
50090-4339-2IBU30 in 1 BOTTLETABLET302
50090-4339-3IBU45 in 1 BOTTLETABLET452
50090-4339-4IBU60 in 1 BOTTLETABLET602
50090-4339-5IBU100 in 1 BOTTLETABLET1002
50090-4339-7IBU21 in 1 BOTTLETABLET212
50090-4339-8IBU12 in 1 BOTTLETABLET122
50090-4339-9IBU40 in 1 BOTTLETABLET402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4339IBU (IBUPROFEN) TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 9 package rows20190626_fb94a1a7-8f10-48eb-a3d3-fe91cc402f77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206917Ibu 800 MG Oral TabletPSNfb94a1a7-8f10-48eb-a3d3-fe91cc402f772
197807ibuprofen 800 MG Oral TabletPSNfb94a1a7-8f10-48eb-a3d3-fe91cc402f772
206917ibuprofen 800 MG Oral Tablet [Ibu]SBDfb94a1a7-8f10-48eb-a3d3-fe91cc402f772
197807ibuprofen 800 MG Oral TabletSCDfb94a1a7-8f10-48eb-a3d3-fe91cc402f772
206917Ibu 800 MG Oral TabletSYfb94a1a7-8f10-48eb-a3d3-fe91cc402f772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4339-05009043390010 TABLET in 1 BOTTLE (50090-4339-0) 10 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-15009043390115 TABLET in 1 BOTTLE (50090-4339-1) 15 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-25009043390230 TABLET in 1 BOTTLE (50090-4339-2) 30 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-35009043390345 TABLET in 1 BOTTLE (50090-4339-3) 45 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-45009043390460 TABLET in 1 BOTTLE (50090-4339-4) 60 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-550090433905100 TABLET in 1 BOTTLE (50090-4339-5) 100 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-75009043390721 TABLET in 1 BOTTLE (50090-4339-7) 21 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-85009043390812 TABLET in 1 BOTTLE (50090-4339-8) 12 tablet2019-06-040000-00-00NoNoCurrent
50090-4339-95009043390940 TABLET in 1 BOTTLE (50090-4339-9) 40 tablet2019-06-040000-00-00NoNoCurrent