IBU

Product NDC
53217-366
11-digit product format
532170366
Labeler code
53217
Product ID
53217-366_caf67aca-5732-4e58-85d2-f70e72e69e4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075682
Marketing category
ANDA
Marketing start
2018-02-09
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
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
53217-366-302020-01-31C16284748780-19d75b9d0-0b02-f424-e053-dadaa90a57ceIBU ™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-366-30IBU30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-366IBU (IBUPROFEN) TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180821_3f99a703-ad40-4fa9-9a41-8b0dec26f515.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206905Ibu 400 MG Oral TabletPSN3f99a703-ad40-4fa9-9a41-8b0dec26f5151
197805ibuprofen 400 MG Oral TabletPSN3f99a703-ad40-4fa9-9a41-8b0dec26f5151
206905ibuprofen 400 MG Oral Tablet [Ibu]SBD3f99a703-ad40-4fa9-9a41-8b0dec26f5151
197805ibuprofen 400 MG Oral TabletSCD3f99a703-ad40-4fa9-9a41-8b0dec26f5151
206905Ibu 400 MG Oral TabletSY3f99a703-ad40-4fa9-9a41-8b0dec26f5151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-366-305321703663030 in 1 BOTTLEHistorical