FDA.reportPublic FDA data

Ibuprofen

Product NDC
72189-556
11-digit product format
721890556
Labeler code
72189
Product ID
72189-556_4c4c7dc3-d5c8-f3d9-e063-6294a90a426f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA213794
Marketing category
ANDA
Marketing start
2024-06-11
Substance
IBUPROFEN
Active strength
800 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-556-20Ibuprofen20 in 1 BOTTLETABLET208
72189-556-21Ibuprofen21 in 1 BOTTLETABLET218
72189-556-30Ibuprofen30 in 1 BOTTLETABLET308
72189-556-40Ibuprofen40 in 1 BOTTLETABLET408
72189-556-45Ibuprofen45 in 1 BOTTLETABLET458
72189-556-60Ibuprofen60 in 1 BOTTLETABLET608
72189-556-71Ibuprofen100 in 1 BOTTLETABLET1008
72189-556-90Ibuprofen90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-556IBUPROFEN TABLET [DIRECT_RX]6Current NDC, 8 package rows20250328_1aa11b52-1aca-9219-e063-6294a90a470f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN1aa11b52-1aca-9219-e063-6294a90a470f8
197807ibuprofen 800 MG Oral TabletSCD1aa11b52-1aca-9219-e063-6294a90a470f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-556-207218905562020 TABLET in 1 BOTTLE (72189-556-20) 20 tablet2024-06-11NoNoCurrent
72189-556-217218905562121 TABLET in 1 BOTTLE (72189-556-21) 21 tablet2024-06-11NoNoCurrent
72189-556-307218905563030 TABLET in 1 BOTTLE (72189-556-30) 30 tablet2024-06-11NoNoCurrent
72189-556-407218905564040 TABLET in 1 BOTTLE (72189-556-40) 40 tablet2024-06-11NoNoCurrent
72189-556-457218905564545 TABLET in 1 BOTTLE (72189-556-45) 45 tablet2024-06-11NoNoCurrent
72189-556-607218905566060 TABLET in 1 BOTTLE (72189-556-60) 60 tablet2024-06-11NoNoCurrent
72189-556-7172189055671100 TABLET in 1 BOTTLE (72189-556-71) 100 tablet2024-06-11NoNoCurrent
72189-556-907218905569090 TABLET in 1 BOTTLE (72189-556-90) 90 tablet2024-06-11NoNoCurrent