FDA.reportPublic FDA data

ibuprofen

Product NDC
67046-314
11-digit product format
670460314
Labeler code
67046
Product ID
67046-314_5ad11b1a-77a1-0ad1-e053-2a91aa0a6f2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090796
Marketing category
ANDA
Marketing start
2017-10-05
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
2019-12-31
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
67046-314-072020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg
67046-314-142020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg
67046-314-152020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg
67046-314-202020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg
67046-314-212020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg
67046-314-282020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg
67046-314-302020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg
67046-314-602020-01-31C16284748780-19d75b9d0-3382-f424-e053-dadaa90a57ce314 Ibuprofen 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-314-07ibuprofen7 in 1 BLISTER PACKTABLET71
67046-314-14ibuprofen14 in 1 BLISTER PACKTABLET141
67046-314-15ibuprofen15 in 1 BLISTER PACKTABLET151
67046-314-20ibuprofen20 in 1 BLISTER PACKTABLET201
67046-314-21ibuprofen21 in 1 BLISTER PACKTABLET211
67046-314-28ibuprofen28 in 1 BLISTER PACKTABLET281
67046-314-30ibuprofen30 in 1 BLISTER PACKTABLET301
67046-314-60ibuprofen60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-314IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20171005_5ad11b1a-77a0-0ad1-e053-2a91aa0a6f2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN5ad11b1a-77a0-0ad1-e053-2a91aa0a6f2e1
197807ibuprofen 800 MG Oral TabletSCD5ad11b1a-77a0-0ad1-e053-2a91aa0a6f2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-314-07670460314077 in 1 BLISTER PACKHistorical
67046-314-146704603141414 in 1 BLISTER PACKHistorical
67046-314-156704603141515 in 1 BLISTER PACKHistorical
67046-314-206704603142020 in 1 BLISTER PACKHistorical
67046-314-216704603142121 in 1 BLISTER PACKHistorical
67046-314-286704603142828 in 1 BLISTER PACKHistorical
67046-314-306704603143030 in 1 BLISTER PACKHistorical
67046-314-606704603146060 in 1 BLISTER PACKHistorical