IBUPROFEN

Product NDC
50090-5159
11-digit product format
500905159
Labeler code
50090
Product ID
50090-5159_88589883-b891-41e8-9cb8-dcb0dec16b28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 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
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50090-5159-02023-01-30C16284748780-1f386c649-fb4c-0266-e053-dadaa90a7c1aIBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
50090-5159-22023-01-30C16284748780-1f386c649-fb4c-0266-e053-dadaa90a7c1aIBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5159-0IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED903
50090-5159-2IBUPROFEN28 in 1 BOTTLETABLET, FILM COATED283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5159IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210602_03c44243-c1f5-4e0d-8cf8-dfda03cfbb5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN03c44243-c1f5-4e0d-8cf8-dfda03cfbb5d3
197805ibuprofen 400 MG Oral TabletSCD03c44243-c1f5-4e0d-8cf8-dfda03cfbb5d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5159-05009051590090 TABLET, FILM COATED in 1 BOTTLE (50090-5159-0) 2020-09-210000-00-00NoNoCurrent
50090-5159-25009051590228 TABLET, FILM COATED in 1 BOTTLE (50090-5159-2) 2020-09-210000-00-00NoNoCurrent