Ibuprofen

Product NDC
42582-112
11-digit product format
425820112
Labeler code
42582
Product ID
42582-112_05d99583-4696-4820-bc05-ed708b6049c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Coastal Pharma International LLC
Application
ANDA090796
Marketing category
ANDA
Marketing start
2016-04-14
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
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
42582-112-102020-01-31C16284748780-19d75b9d0-4be8-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
42582-112-182020-01-31C16284748780-19d75b9d0-4be8-f424-e053-dadaa90a57ceIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-112-10Ibuprofen100 in 1 BOTTLETABLET1001
42582-112-18Ibuprofen500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-112IBUPROFEN TABLET [BI-COASTAL PHARMA INTERNATIONAL LLC]1Legacy NDC, 2 package rows20160418_9c4d2f91-5db5-4f8f-bb95-eb4dec94a6cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN50361fc8-8fbc-1c45-e054-00144ff88e883
197806ibuprofen 600 MG Oral TabletSCD50361fc8-8fbc-1c45-e054-00144ff88e883
197805ibuprofen 400 MG Oral TabletPSN9c4d2f91-5db5-4f8f-bb95-eb4dec94a6cc1
197806ibuprofen 600 MG Oral TabletPSN9c4d2f91-5db5-4f8f-bb95-eb4dec94a6cc1
197807ibuprofen 800 MG Oral TabletPSN9c4d2f91-5db5-4f8f-bb95-eb4dec94a6cc1
197805ibuprofen 400 MG Oral TabletSCD9c4d2f91-5db5-4f8f-bb95-eb4dec94a6cc1
197806ibuprofen 600 MG Oral TabletSCD9c4d2f91-5db5-4f8f-bb95-eb4dec94a6cc1
197807ibuprofen 800 MG Oral TabletSCD9c4d2f91-5db5-4f8f-bb95-eb4dec94a6cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42582-112-1042582011210100 in 1 BOTTLEHistorical
42582-112-1842582011218500 in 1 BOTTLEHistorical