FDA.reportPublic FDA data

Ibuprofen

Product NDC
80425-0046
11-digit product format
804250046
Labeler code
80425
Product ID
80425-0046_3bcc8b5e-85c7-fb7e-e063-6294a90a3cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
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
80425-0046-1Ibuprofen90 in 1 BOTTLETABLET, FILM COATED9010
80425-0046-2Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12010
80425-0046-3Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6010
80425-0046-4Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3010
80425-0046-5Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0046-1EA - Each80425-004662581d8b-2f74-46b8-863f-a79f6a44d7a512023-06-06
80425-0046-2EA - Each80425-0046155f2633-4c11-401d-b550-262b6ca9e2c512023-06-06
80425-0046-3EA - Each80425-00464fdfb716-6522-430f-a2ba-d234476a568612023-06-06
80425-0046-4EA - Each80425-0046c97f3641-cd80-4bf6-9b61-25a0bd8be5a912023-06-06
80425-0046-5EA - Each80425-00464b9256f5-33f7-42a3-86fb-30d523c705b612025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0046IBUPROFEN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 5 package rows20250101_af9ac948-440c-5abf-e053-2995a90af2b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNaf9ac948-440c-5abf-e053-2995a90af2b510
197807ibuprofen 800 MG Oral TabletSCDaf9ac948-440c-5abf-e053-2995a90af2b510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0046-18042500460190 TABLET, FILM COATED in 1 BOTTLE (80425-0046-1) 2015-12-210000-00-00NoNoCurrent
80425-0046-280425004602120 TABLET, FILM COATED in 1 BOTTLE (80425-0046-2) 2015-12-210000-00-00NoNoCurrent
80425-0046-38042500460360 TABLET, FILM COATED in 1 BOTTLE (80425-0046-3) 2015-12-210000-00-00NoNoCurrent
80425-0046-48042500460430 TABLET, FILM COATED in 1 BOTTLE (80425-0046-4) 2015-12-210000-00-00NoNoCurrent
80425-0046-580425004605100 TABLET, FILM COATED in 1 BOTTLE (80425-0046-5) 2015-12-21NoNoHistorical