FDA.reportPublic FDA data

IBUPROFEN

Product NDC
72189-266
11-digit product format
721890266
Labeler code
72189
Product ID
72189-266_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
2021-09-16
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
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
IBUPROFEN800 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
72189-266-15IBUPROFEN15 in 1 BOTTLETABLET, FILM COATED1511
72189-266-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED3011
72189-266-40IBUPROFEN40 in 1 BOTTLETABLET, FILM COATED4011
72189-266-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED6011
72189-266-71IBUPROFEN100 in 1 BOTTLETABLET, FILM COATED10011
72189-266-72IBUPROFEN120 in 1 BOTTLETABLET, FILM COATED12011
72189-266-90IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-266-15EA - Each72189-266dc7ac00e-9214-4201-a6be-71e538d5638b12022-03-09
72189-266-30EA - Each72189-266f44d3f61-391b-4462-835e-c18de5f1b44412022-07-06
72189-266-40EA - Each72189-266b360d924-dfa1-477b-ac95-f52e565809b212021-10-08
72189-266-60EA - Each72189-2662022e072-c0b1-4287-85fe-696c81726cd712022-02-07
72189-266-71EA - Each72189-2660e5026a0-f904-4827-aaa9-d6298be1968f12021-11-09
72189-266-72EA - Each72189-266db3c2592-136f-4b86-a273-96135df831da12022-02-07
72189-266-90EA - Each72189-266691aa9da-d86b-41ed-967d-2bc8a56f3aae12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-266IBUPROFEN TABLET, FILM COATED [DIRECT RX]11Current NDC, Legacy NDC, 7 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
72189-266-157218902661515 TABLET, FILM COATED in 1 BOTTLE (72189-266-15) 2021-09-160000-00-00NoNoCurrent
72189-266-307218902663030 TABLET, FILM COATED in 1 BOTTLE (72189-266-30) 2021-09-160000-00-00NoNoCurrent
72189-266-407218902664040 TABLET, FILM COATED in 1 BOTTLE (72189-266-40) 2021-09-160000-00-00NoNoCurrent
72189-266-607218902666060 TABLET, FILM COATED in 1 BOTTLE (72189-266-60) 2021-09-160000-00-00NoNoCurrent
72189-266-7172189026671100 TABLET, FILM COATED in 1 BOTTLE (72189-266-71) 2021-09-160000-00-00NoNoCurrent
72189-266-7272189026672120 TABLET, FILM COATED in 1 BOTTLE (72189-266-72) 2021-09-160000-00-00NoNoCurrent
72189-266-907218902669090 TABLET, FILM COATED in 1 BOTTLE (72189-266-90) 2021-09-160000-00-00NoNoCurrent