Ibuprofen

Product NDC
45865-474
11-digit product format
458650474
Labeler code
45865
Product ID
45865-474_9ab2a40b-54a5-3088-e053-2a95a90a233c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
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
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
45865-474-602025-01-30C16284748780-12cef2736-9efd-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP RX Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-474-60Ibuprofen60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-474IBUPROFEN TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_1ddb2839-218a-2176-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN1ddb2839-218a-2176-e054-00144ff88e882
197805ibuprofen 400 MG Oral TabletSCD1ddb2839-218a-2176-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-474-604586504746060 TABLET in 1 BOTTLE (45865-474-60) 60 tablet2015-08-260000-00-00NoNoCurrent