FDA.reportPublic FDA data

Ibuprofen

Product NDC
42708-097
11-digit product format
427080097
Labeler code
42708
Product ID
42708-097_45868a0c-2a62-c1fa-e063-6294a90a1805
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
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
Ibuprofen
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
42708-097-302021-03-15C16284748780-1ba0f9c33-1d15-a910-e053-dadaa90a0b85IBUPROFEN 600 MG TABLETS
42708-097-602021-03-15C16284748780-1ba0f9c33-1d15-a910-e053-dadaa90a0b85IBUPROFEN 600 MG TABLETS
42708-097-302021-01-29C16284748780-1ba0f9c33-1d15-a910-e053-dadaa90a0b85IBUPROFEN 600 MG TABLETS
42708-097-602021-01-29C16284748780-1ba0f9c33-1d15-a910-e053-dadaa90a0b85IBUPROFEN 600 MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-097-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-097IBUPROFEN TABLET, FILM COATED [QPHARMA, INC.]9Current NDC, Legacy NDC, 1 package rows20250521_f452d2c3-525f-4933-b146-92351d0ae44f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNf452d2c3-525f-4933-b146-92351d0ae44f10
197806ibuprofen 600 MG Oral TabletSCDf452d2c3-525f-4933-b146-92351d0ae44f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-097-304270800973030 TABLET, FILM COATED in 1 BOTTLE (42708-097-30) 2019-05-310000-00-00YesNoCurrent
42708-097-604270800976060 TABLET, FILM COATED in 1 BOTTLE (42708-097-60) 2018-03-210000-00-00YesNoCurrent