FDA.reportPublic FDA data

IBU

Product NDC
67296-0913
11-digit product format
672960913
Labeler code
67296
Product ID
67296-0913_3251a7a8-7561-cf22-e063-6394a90adcb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBU
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA075682
Marketing category
ANDA
Marketing start
2008-11-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBU
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
67296-0913-12024-07-11C16284748780-11030e365-3c99-111a-e063-dadaa90a10e24db219dc-ea48-490c-e054-00144ff88e88
67296-0913-32024-07-11C16284748780-11030e365-3c99-111a-e063-dadaa90a10e24db219dc-ea48-490c-e054-00144ff88e88
67296-0913-12024-01-30C16284748780-11030e365-3c99-111a-e063-dadaa90a10e24db219dc-ea48-490c-e054-00144ff88e88
67296-0913-32024-01-30C16284748780-11030e365-3c99-111a-e063-dadaa90a10e24db219dc-ea48-490c-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0913-1IBU30 in 1 BOTTLETABLET306
67296-0913-3IBU10 in 1 BOTTLETABLET106
67296-0913-9IBU90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0913IBU TABLET [REDPHARM DRUG, INC.]6Current NDC, Legacy NDC, 3 package rows20250410_4db219dc-ea48-490c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN4db219dc-ea48-490c-e054-00144ff88e886
197806ibuprofen 600 MG Oral TabletSCD4db219dc-ea48-490c-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0913-16729609130130 TABLET in 1 BOTTLE (67296-0913-1) 30 tablet2008-11-200000-00-00NoNoCurrent
67296-0913-36729609130310 TABLET in 1 BOTTLE (67296-0913-3) 10 tablet2008-11-200000-00-00NoNoCurrent
67296-0913-96729609130990 TABLET in 1 BOTTLE (67296-0913-9) 90 tablet2008-11-20NoNoHistorical