FDA.reportPublic FDA data

Ibuprofen

Product NDC
80425-0047
11-digit product format
804250047
Labeler code
80425
Product ID
80425-0047_2a989dd1-65cc-966d-e063-6294a90ae8ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
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
80425-0047-1Ibuprofen90 in 1 BOTTLETABLET9010
80425-0047-2Ibuprofen120 in 1 BOTTLETABLET12010
80425-0047-3Ibuprofen60 in 1 BOTTLETABLET6010
80425-0047-4Ibuprofen30 in 1 BOTTLETABLET3010
80425-0047-5Ibuprofen100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0047-1EA - Each80425-0047cce99f72-1868-4ec8-8dd8-f62ab982c3f212023-06-06
80425-0047-2EA - Each80425-00472d464f5f-d400-4b3d-948e-c5886834fbd612023-06-06
80425-0047-3EA - Each80425-00479277e913-d2a3-4810-95d4-5f915f0ae56d12023-06-06
80425-0047-4EA - Each80425-0047ca22b8d2-c06f-480c-b2b0-57dc2d1f2c1412023-06-06
80425-0047-5EA - Each80425-0047bf65fd94-4f11-460d-8b9a-1bc2ada26d7c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0047IBUPROFEN TABLET [ADVANCED RX OF TENNESSEE, LLC]10Current NDC, Legacy NDC, 5 package rows20250101_af9af7f4-6314-6217-e053-2995a90a5a0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNaf9af7f4-6314-6217-e053-2995a90a5a0f10
197807ibuprofen 800 MG Oral TabletSCDaf9af7f4-6314-6217-e053-2995a90a5a0f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0047-18042500470190 TABLET in 1 BOTTLE (80425-0047-1) 90 tablet2009-11-230000-00-00NoNoCurrent
80425-0047-280425004702120 TABLET in 1 BOTTLE (80425-0047-2) 120 tablet2009-11-230000-00-00NoNoCurrent
80425-0047-38042500470360 TABLET in 1 BOTTLE (80425-0047-3) 60 tablet2009-11-230000-00-00NoNoCurrent
80425-0047-48042500470430 TABLET in 1 BOTTLE (80425-0047-4) 30 tablet2009-11-230000-00-00NoNoCurrent
80425-0047-580425004705100 TABLET in 1 BOTTLE (80425-0047-5) 100 tablet2009-11-230000-00-00NoNoCurrent