FDA.reportPublic FDA data

Ibuprofen

Product NDC
50436-0319
11-digit product format
504360319
Labeler code
50436
Product ID
50436-0319_799c662c-30bf-4859-9f90-97ab32371696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
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
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
50436-0319-12023-01-30C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-62023-01-30C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-72023-01-30C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-12021-08-24C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-62021-08-24C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-72021-08-24C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-12021-01-29C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-62021-01-29C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP
50436-0319-72021-01-29C16284748780-1ba0f9c33-37b3-a910-e053-dadaa90a0b85IBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0319-1Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3012
50436-0319-6Ibuprofen40 in 1 BOTTLETABLET, FILM COATED4012
50436-0319-7Ibuprofen12 in 1 BOTTLETABLET, FILM COATED1212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0319IBUPROFEN TABLET, FILM COATED [UNIT DOSE SERVICES]12Legacy NDC, 3 package rows20210825_a4c74188-9af6-422c-abd9-087a8ab4b43a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNa4c74188-9af6-422c-abd9-087a8ab4b43a12
197806ibuprofen 600 MG Oral TabletPSNa4c74188-9af6-422c-abd9-087a8ab4b43a12
197807ibuprofen 800 MG Oral TabletPSNa4c74188-9af6-422c-abd9-087a8ab4b43a12
197805ibuprofen 400 MG Oral TabletSCDa4c74188-9af6-422c-abd9-087a8ab4b43a12
197806ibuprofen 600 MG Oral TabletSCDa4c74188-9af6-422c-abd9-087a8ab4b43a12
197807ibuprofen 800 MG Oral TabletSCDa4c74188-9af6-422c-abd9-087a8ab4b43a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0319-15043603190130 TABLET, FILM COATED in 1 BOTTLE (50436-0319-1) 2018-06-050000-00-00NoNoCurrent
50436-0319-65043603190640 TABLET, FILM COATED in 1 BOTTLE (50436-0319-6) 2018-06-050000-00-00NoNoCurrent
50436-0319-75043603190712 TABLET, FILM COATED in 1 BOTTLE (50436-0319-7) 2018-06-050000-00-00NoNoCurrent