FDA.reportPublic FDA data

Ibuprofen

Product NDC
80425-0089
11-digit product format
804250089
Labeler code
80425
Product ID
80425-0089_2a9914b1-cac7-a414-e063-6394a90a6f0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
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
Rxcui197807

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
80425-0089-1Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3010
80425-0089-2Ibuprofen90 in 1 BOTTLETABLET, FILM COATED9010
80425-0089-3Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12010
80425-0089-4Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0089-1EA - Each80425-008901ce4c5e-17ef-4f4b-b965-568a87abebf112023-06-06
80425-0089-2EA - Each80425-00896ac60d16-43c1-486a-a4a2-aeae77dad7cb12023-06-06
80425-0089-3EA - Each80425-0089f137aff3-c81c-4c4d-ab0a-27b16fd37c1512023-06-06
80425-0089-4EA - Each80425-0089f74fc782-5cf4-468d-8455-425ded548afa12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0089IBUPROFEN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]10Current NDC, Legacy NDC, 4 package rows20250101_b33caad1-8d40-16f2-e053-2a95a90a1b2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNb33caad1-8d40-16f2-e053-2a95a90a1b2d10
197807ibuprofen 800 MG Oral TabletSCDb33caad1-8d40-16f2-e053-2a95a90a1b2d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0089-18042500890130 TABLET, FILM COATED in 1 BOTTLE (80425-0089-1) 2015-12-300000-00-00NoNoCurrent
80425-0089-28042500890290 TABLET, FILM COATED in 1 BOTTLE (80425-0089-2) 2015-12-300000-00-00NoNoCurrent
80425-0089-380425008903120 TABLET, FILM COATED in 1 BOTTLE (80425-0089-3) 2015-12-300000-00-00NoNoCurrent
80425-0089-48042500890460 TABLET, FILM COATED in 1 BOTTLE (80425-0089-4) 2015-12-300000-00-00NoNoCurrent