FDA.reportPublic FDA data

IBUPROFEN

Product NDC
72189-231
11-digit product format
721890231
Labeler code
72189
Product ID
72189-231_2c285455-94b8-8154-e063-6394a90a0e8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090796
Marketing category
ANDA
Marketing start
2021-06-04
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, 197807

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-231-21IBUPROFEN21 in 1 BOTTLETABLET, FILM COATED2111
72189-231-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED3011
72189-231-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED6011
72189-231-90IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-231IBUPROFEN TABLET, FILM COATED [DIRECT RX]11Current NDC, Legacy NDC, 4 package rows20250121_c3f30813-0848-6e8a-e053-2995a90a3dea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNc3f30813-0848-6e8a-e053-2995a90a3dea11
197807ibuprofen 800 MG Oral TabletPSNc3f30813-0848-6e8a-e053-2995a90a3dea11
197806ibuprofen 600 MG Oral TabletSCDc3f30813-0848-6e8a-e053-2995a90a3dea11
197807ibuprofen 800 MG Oral TabletSCDc3f30813-0848-6e8a-e053-2995a90a3dea11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-231-217218902312121 TABLET, FILM COATED in 1 BOTTLE (72189-231-21) 2021-06-040000-00-00NoNoCurrent
72189-231-307218902313030 TABLET, FILM COATED in 1 BOTTLE (72189-231-30) 2021-06-040000-00-00NoNoCurrent
72189-231-607218902316060 TABLET, FILM COATED in 1 BOTTLE (72189-231-60) 2021-06-040000-00-00NoNoCurrent
72189-231-907218902319090 TABLET, FILM COATED in 1 BOTTLE (72189-231-90) 2021-06-040000-00-00NoNoCurrent