Ibuprofen

Product NDC
67046-688
11-digit product format
670460688
Labeler code
67046
Product ID
67046-688_7e2a4db3-99cb-1b56-e053-2a91aa0a9238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090796
Marketing category
ANDA
Marketing start
2018-02-15
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
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
67046-688-302022-01-28C16284748780-1d6a99b39-4fed-a426-e053-dadaa90af4c2Ibuprofen 600mg USP 688
67046-688-602022-01-28C16284748780-1d6a99b39-4fed-a426-e053-dadaa90af4c2Ibuprofen 600mg USP 688

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-688-30Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED302
67046-688-60Ibuprofen60 in 1 BLISTER PACKTABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-688IBUPROFEN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 2 package rows20181230_6a346e13-ada1-be3a-e053-2991aa0abba6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN6a346e13-ada1-be3a-e053-2991aa0abba62
197806ibuprofen 600 MG Oral TabletSCD6a346e13-ada1-be3a-e053-2991aa0abba62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-688-306704606883030 TABLET, FILM COATED in 1 BLISTER PACK (67046-688-30) 2018-02-150000-00-00NoNoCurrent
67046-688-606704606886060 TABLET, FILM COATED in 1 BLISTER PACK (67046-688-60) 2018-02-150000-00-00NoNoCurrent