FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-4230
11-digit product format
500904230
Labeler code
50090
Product ID
50090-4230_39dfd833-4e95-4e49-871f-40e0446ff886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202413
Marketing category
ANDA
Marketing start
2017-04-15
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
50090-4230-02023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-12023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-22023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-32023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-42023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-52023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-72023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-82023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS
50090-4230-92023-01-30C16284748780-1f386c649-fb9f-0266-e053-dadaa90a7c1aIBUPROFEN TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4230-0Ibuprofen10 in 1 BOTTLETABLET101
50090-4230-1Ibuprofen12 in 1 BOTTLETABLET121
50090-4230-2Ibuprofen16 in 1 BOTTLETABLET161
50090-4230-3Ibuprofen30 in 1 BOTTLETABLET301
50090-4230-4Ibuprofen60 in 1 BOTTLETABLET601
50090-4230-5Ibuprofen100 in 1 BOTTLETABLET1001
50090-4230-7Ibuprofen40 in 1 BOTTLETABLET401
50090-4230-8Ibuprofen20 in 1 BOTTLETABLET201
50090-4230-9Ibuprofen24 in 1 BOTTLETABLET241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4230IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 9 package rows20190402_18069b35-7118-404e-a6c1-946f3c71164c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN18069b35-7118-404e-a6c1-946f3c71164c1
197806ibuprofen 600 MG Oral TabletSCD18069b35-7118-404e-a6c1-946f3c71164c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4230-05009042300010 TABLET in 1 BOTTLE (50090-4230-0) 10 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-15009042300112 TABLET in 1 BOTTLE (50090-4230-1) 12 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-25009042300216 TABLET in 1 BOTTLE (50090-4230-2) 16 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-35009042300330 TABLET in 1 BOTTLE (50090-4230-3) 30 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-45009042300460 TABLET in 1 BOTTLE (50090-4230-4) 60 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-550090423005100 TABLET in 1 BOTTLE (50090-4230-5) 100 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-75009042300740 TABLET in 1 BOTTLE (50090-4230-7) 40 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-85009042300820 TABLET in 1 BOTTLE (50090-4230-8) 20 tablet2019-03-270000-00-00NoNoCurrent
50090-4230-95009042300924 TABLET in 1 BOTTLE (50090-4230-9) 24 tablet2019-03-270000-00-00NoNoCurrent