Ibuprofen

Product NDC
85509-1466
11-digit product format
855091466
Labeler code
85509
Product ID
85509-1466_40202c76-4276-88fd-e063-6394a90a07b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
PHOENIX RX 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
85509-1466-3Ibuprofen30 in 1 BOTTLETABLET301
85509-1466-6Ibuprofen60 in 1 BOTTLETABLET601
85509-1466-9Ibuprofen90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1466-3EA - Each85509-1466dbf69f08-7cbd-4190-b0ec-8fc01cebc9de12025-11-13
85509-1466-6EA - Each85509-146663545523-0e4e-4ac8-aecb-36fb2df50e1b12025-11-13
85509-1466-9EA - Each85509-1466ac46d50e-6d7c-4fbd-b857-64568879138212025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN40202c76-4275-88fd-e063-6394a90a07b21
197807ibuprofen 800 MG Oral TabletSCD40202c76-4275-88fd-e063-6394a90a07b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-1466-38550914660330 TABLET in 1 BOTTLE (85509-1466-3) 30 tablet2025-10-01NoNoHistorical
85509-1466-68550914660660 TABLET in 1 BOTTLE (85509-1466-6) 60 tablet2025-10-01NoNoHistorical
85509-1466-98550914660990 TABLET in 1 BOTTLE (85509-1466-9) 90 tablet2025-10-01NoNoHistorical