FDA.reportPublic FDA data

IBUPROFEN

Product NDC
61919-628
11-digit product format
619190628
Labeler code
61919
Product ID
61919-628_edad129d-d395-5999-e053-2a95a90a47f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA091625
Marketing category
ANDA
Marketing start
2019-08-20
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
61919-628-212025-01-30C16284748780-12cef2736-b0c7-d83d-e063-dadaa90ab31fIBUPROFEN
61919-628-302025-01-30C16284748780-12cef2736-8b20-d83d-e063-dadaa90ab31fIBUPROFEN
61919-628-602025-01-30C16284748780-12cef2736-b0c7-d83d-e063-dadaa90ab31fIBUPROFEN
61919-628-902025-01-30C16284748780-12cef2736-b0c7-d83d-e063-dadaa90ab31fIBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-628-21IBUPROFEN21 in 1 BOTTLETABLET, FILM COATED214
61919-628-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED604
61919-628-90IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED904
61919-628-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-628-21EA - Each61919-628a3a67547-4a69-43b4-89d2-7cd1e656c75912019-09-05
61919-628-30EA - Each61919-628a78afcb2-87c0-40e4-9df7-dd65c05e732f12019-04-11
61919-628-60EA - Each61919-6280a00b310-5a22-445e-b060-54c1a0a71feb12022-10-06
61919-628-90EA - Each61919-628f3ee5e17-c10a-413c-bd6c-922d1ee63b9b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-628IBUPROFEN TABLET, FILM COATED [DIRECT_RX]4Legacy NDC, 3 package rows20230510_908e2b06-f642-db7c-e053-2995a90a51a4.zip
61919-628IBUPROFEN (IBUOROFEN) TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20190330_67377024-fe71-4fa0-e053-2991aa0afba2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN908e2b06-f642-db7c-e053-2995a90a51a44
197806ibuprofen 600 MG Oral TabletSCD908e2b06-f642-db7c-e053-2995a90a51a44
197806ibuprofen 600 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197806ibuprofen 600 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-628-216191906282121 TABLET, FILM COATED in 1 BOTTLE (61919-628-21) 2019-08-200000-00-00NoNoCurrent
61919-628-306191906283030 TABLET, FILM COATED in 1 BOTTLE (61919-628-30) 2019-03-290000-00-00NoNoCurrent
61919-628-606191906286060 TABLET, FILM COATED in 1 BOTTLE (61919-628-60) 2019-08-200000-00-00NoNoCurrent
61919-628-906191906289090 TABLET, FILM COATED in 1 BOTTLE (61919-628-90) 2019-08-200000-00-00NoNoCurrent