FDA.reportPublic FDA data

Ibuprofen

Product NDC
43353-095
11-digit product format
433530095
Labeler code
43353
Product ID
43353-095_76a978ee-0dd7-4ab7-ae41-4d052f151dd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075682
Marketing category
ANDA
Marketing start
2009-06-10
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
43353-095-602023-01-30C16284748780-1f386c64a-1284-0266-e053-dadaa90a7c1aIBU ™ Tablets
43353-095-802023-01-30C16284748780-1f386c64a-1284-0266-e053-dadaa90a7c1aIBU ™ Tablets
43353-095-922023-01-30C16284748780-1f386c64a-1284-0266-e053-dadaa90a7c1aIBU ™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-095-60Ibuprofen90 in 1 BOTTLETABLET, FILM COATED905
43353-095-80Ibuprofen180 in 1 BOTTLETABLET, FILM COATED1805
43353-095-92Ibuprofen270 in 1 BOTTLETABLET, FILM COATED2705

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-095-60EA - Each43353-0957f8013d3-dc35-4dba-8a0c-524c263fafad12016-09-02
43353-095-80EA - Each43353-0952b083e14-2d73-441d-ad45-d1277e822db412017-03-06
43353-095-92EA - Each43353-095f0516dfd-e144-4929-a7dc-362aff565e0e12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-095IBUPROFEN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Legacy NDC, 3 package rows20191228_9b6c3c52-404e-4168-94d2-2500a91a3bc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN9b6c3c52-404e-4168-94d2-2500a91a3bc65
197807ibuprofen 800 MG Oral TabletPSN9b6c3c52-404e-4168-94d2-2500a91a3bc65
197806ibuprofen 600 MG Oral TabletSCD9b6c3c52-404e-4168-94d2-2500a91a3bc65
197807ibuprofen 800 MG Oral TabletSCD9b6c3c52-404e-4168-94d2-2500a91a3bc65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-095-604335300956090 TABLET, FILM COATED in 1 BOTTLE (43353-095-60) 2015-08-090000-00-00NoNoCurrent
43353-095-8043353009580180 TABLET, FILM COATED in 1 BOTTLE (43353-095-80) 2015-08-090000-00-00NoNoCurrent
43353-095-9243353009592270 TABLET, FILM COATED in 1 BOTTLE (43353-095-92) 2017-07-310000-00-00NoNoCurrent