FDA.reportPublic FDA data

IBU

Product NDC
50090-4331
11-digit product format
500904331
Labeler code
50090
Product ID
50090-4331_2e87857a-e8e7-4e9f-ab8a-3d8f373a4281
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
600 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
50090-4331-02023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-12023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-22023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-32023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-42023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-52023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-72023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-82023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets
50090-4331-92023-01-30C16284748780-1f386c64a-4036-0266-e053-dadaa90a7c1aIBU ™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4331-0IBU10 in 1 BOTTLETABLET102
50090-4331-1IBU12 in 1 BOTTLETABLET122
50090-4331-2IBU16 in 1 BOTTLETABLET162
50090-4331-3IBU30 in 1 BOTTLETABLET302
50090-4331-4IBU60 in 1 BOTTLETABLET602
50090-4331-5IBU100 in 1 BOTTLETABLET1002
50090-4331-7IBU40 in 1 BOTTLETABLET402
50090-4331-8IBU20 in 1 BOTTLETABLET202
50090-4331-9IBU24 in 1 BOTTLETABLET242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4331IBU (IBUPROFEN) TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 9 package rows20190626_0d4ce1a2-835b-4837-a76c-6bac61219136.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206913Ibu 600 MG Oral TabletPSN0d4ce1a2-835b-4837-a76c-6bac612191362
197806ibuprofen 600 MG Oral TabletPSN0d4ce1a2-835b-4837-a76c-6bac612191362
206913ibuprofen 600 MG Oral Tablet [Ibu]SBD0d4ce1a2-835b-4837-a76c-6bac612191362
197806ibuprofen 600 MG Oral TabletSCD0d4ce1a2-835b-4837-a76c-6bac612191362
206913Ibu 600 MG Oral TabletSY0d4ce1a2-835b-4837-a76c-6bac612191362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4331-05009043310010 TABLET in 1 BOTTLE (50090-4331-0) 10 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-15009043310112 TABLET in 1 BOTTLE (50090-4331-1) 12 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-25009043310216 TABLET in 1 BOTTLE (50090-4331-2) 16 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-35009043310330 TABLET in 1 BOTTLE (50090-4331-3) 30 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-45009043310460 TABLET in 1 BOTTLE (50090-4331-4) 60 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-550090433105100 TABLET in 1 BOTTLE (50090-4331-5) 100 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-75009043310740 TABLET in 1 BOTTLE (50090-4331-7) 40 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-85009043310820 TABLET in 1 BOTTLE (50090-4331-8) 20 tablet2019-06-040000-00-00NoNoCurrent
50090-4331-95009043310924 TABLET in 1 BOTTLE (50090-4331-9) 24 tablet2019-06-040000-00-00NoNoCurrent