FDA.reportPublic FDA data

IBUPROFEN

Product NDC
45865-117
11-digit product format
458650117
Labeler code
45865
Product ID
45865-117_b42e36f4-ff24-0b5a-e053-2a95a90ac629
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090796
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 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
2021-12-31
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
45865-117-202025-01-30C16284748780-12cef2736-8cbf-d83d-e063-dadaa90ab31fIBUPROFEN 600 MG TABLETS
45865-117-212025-01-30C16284748780-12cef2736-8cbf-d83d-e063-dadaa90ab31fIBUPROFEN 600 MG TABLETS
45865-117-302025-01-30C16284748780-12cef2736-8cbf-d83d-e063-dadaa90ab31fIBUPROFEN 600 MG TABLETS
45865-117-602025-01-30C16284748780-12cef2736-8cbf-d83d-e063-dadaa90ab31fIBUPROFEN 600 MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-117-20IBUPROFEN20 in 1 BOTTLETABLET, FILM COATED201
45865-117-21IBUPROFEN21 in 1 BOTTLETABLET, FILM COATED211
45865-117-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED301
45865-117-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-117IBUPROFEN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 4 package rows20201117_b42e35f1-0624-2f95-e053-2995a90a52b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNb42e35f1-0624-2f95-e053-2995a90a52b81
197806ibuprofen 600 MG Oral TabletSCDb42e35f1-0624-2f95-e053-2995a90a52b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-117-204586501172020 TABLET, FILM COATED in 1 BOTTLE (45865-117-20) 2020-07-010000-00-00NoNoCurrent
45865-117-214586501172121 TABLET, FILM COATED in 1 BOTTLE (45865-117-21) 2020-07-010000-00-00NoNoCurrent
45865-117-304586501173030 TABLET, FILM COATED in 1 BOTTLE (45865-117-30) 2020-07-010000-00-00NoNoCurrent
45865-117-604586501176060 TABLET, FILM COATED in 1 BOTTLE (45865-117-60) 2020-07-010000-00-00NoNoCurrent