FDA.reportPublic FDA data

ibuprofen

Product NDC
41250-604
11-digit product format
412500604
Labeler code
41250
Product ID
41250-604_4e6148c7-fafa-4303-bc95-1dc96dee075d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA072096
Marketing category
ANDA
Marketing start
1988-02-15
Substance
IBUPROFEN
Active strength
200 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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
41250-604-62ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41250-604-62ibuprofen24 in 1 BOTTLETABLET, FILM COATED248
41250-604-71ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41250-604-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED508
41250-604-76ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41250-604-76ibuprofen120 in 1 BOTTLETABLET, FILM COATED1208
41250-604-78ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41250-604-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
41250-604-82ibuprofen2 in 1 CARTONTABLET, FILM COATED28
41250-604-82ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
41250-604-85ibuprofen250 in 1 BOTTLETABLET, FILM COATED2508
41250-604-90ibuprofen500 in 1 BOTTLETABLET, FILM COATED5008
41250-604-93ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-604IBUPROFEN TABLET, FILM COATED [MEIJER DISTRIBUTION INC]8Current NDC, Legacy NDC, 13 package rows20231010_e578de96-747e-4104-8db6-e6521e6052a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNe578de96-747e-4104-8db6-e6521e6052a58
310965ibuprofen 200 MG Oral TabletSCDe578de96-747e-4104-8db6-e6521e6052a58
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe578de96-747e-4104-8db6-e6521e6052a58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-604-62412500604621 BOTTLE in 1 CARTON (41250-604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1994-09-070000-00-00NoNoCurrent
41250-604-71412500604711 BOTTLE in 1 CARTON (41250-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-02-150000-00-00NoNoCurrent
41250-604-76412500604761 BOTTLE in 1 CARTON (41250-604-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle1992-03-200000-00-00NoNoCurrent
41250-604-78412500604781 BOTTLE in 1 CARTON (41250-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1990-12-150000-00-00NoNoCurrent
41250-604-82412500604822 BOTTLE in 1 CARTON (41250-604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2011-05-130000-00-00NoNoCurrent
41250-604-8541250060485250 TABLET, FILM COATED in 1 BOTTLE (41250-604-85) 2018-04-300000-00-00NoNoCurrent
41250-604-9041250060490500 TABLET, FILM COATED in 1 BOTTLE (41250-604-90) 1992-05-220000-00-00NoNoCurrent
41250-604-93412500604931000 TABLET, FILM COATED in 1 BOTTLE (41250-604-93) 2007-01-170000-00-00NoNoCurrent