IBUPROFEN

Product NDC
72189-324
11-digit product format
721890324
Labeler code
72189
Product ID
72189-324_2c3d44ba-dd1c-19fc-e063-6394a90a15f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct Rx
Application
ANDA090796
Marketing category
ANDA
Marketing start
2022-02-21
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
72189-324-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED305
72189-324-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-324-30EA - Each72189-324ce3aecaa-e976-4f1f-b20c-745529f55fe112022-03-09
72189-324-60EA - Each72189-324625b2cfb-e741-4b80-9e97-c2f4cc58217912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-324IBUPROFEN TABLET, FILM COATED [DIRECT RX]5Current NDC, Legacy NDC, 2 package rows20250122_d88d0544-57a7-4a82-e053-2a95a90a1945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNd88d0544-57a7-4a82-e053-2a95a90a19455
197805ibuprofen 400 MG Oral TabletSCDd88d0544-57a7-4a82-e053-2a95a90a19455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-324-307218903243030 TABLET, FILM COATED in 1 BOTTLE (72189-324-30) 2022-02-210000-00-00NoNoCurrent
72189-324-607218903246060 TABLET, FILM COATED in 1 BOTTLE (72189-324-60) 2022-02-210000-00-00NoNoCurrent