IBUPROFEN

Product NDC
45865-945
11-digit product format
458650945
Labeler code
45865
Product ID
45865-945_9add4144-5841-6d3a-e053-2995a90ac3c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
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
45865-945-302025-01-30C16284748780-12cef2736-8401-d83d-e063-dadaa90ab31fIBUPROFEN 800 MG TABLETS
45865-945-602025-01-30C16284748780-12cef2736-8401-d83d-e063-dadaa90ab31fIBUPROFEN 800 MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-945-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED301
45865-945-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-945IBUPROFEN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20191230_9add412e-3494-4097-e053-2995a90a8fc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN9add412e-3494-4097-e053-2995a90a8fc71
197807ibuprofen 800 MG Oral TabletSCD9add412e-3494-4097-e053-2995a90a8fc71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-945-304586509453030 TABLET, FILM COATED in 1 BOTTLE (45865-945-30) 2018-12-120000-00-00NoNoCurrent
45865-945-604586509456060 TABLET, FILM COATED in 1 BOTTLE (45865-945-60) 2018-12-120000-00-00NoNoCurrent