FDA.reportPublic FDA data

Ibuprofen

Product NDC
0904-5853
11-digit product format
009045853
Labeler code
0904
Product ID
0904-5853_9316ff41-1d6d-4538-821c-6835bfce15eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075682
Marketing category
ANDA
Marketing start
2009-06-10
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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
0904-5853-40Ibuprofen500 in 1 BOTTLETABLET50029
0904-5853-60Ibuprofen100 in 1 BOTTLETABLET10029
0904-5853-61Ibuprofen1 in 1 BLISTER PACKTABLET129
0904-5853-61Ibuprofen100 in 1 CARTONTABLET10029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5853-40EA - Each0904-5853303fe9ff-205e-4c06-aafe-cab7336f91c112013-11-04
0904-5853-61EA - Each0904-585353908c4c-0928-4cf2-ad34-b390f02e9ea312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]16
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BIBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5853IBUPROFEN TABLET [MAJOR PHARMACEUTICALS]25Current NDC, Legacy NDC, 4 package rows20250302_ba86e936-ef72-43e5-aebf-f2c788fe2266.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNba86e936-ef72-43e5-aebf-f2c788fe226629
197806ibuprofen 600 MG Oral TabletPSNba86e936-ef72-43e5-aebf-f2c788fe226629
197807ibuprofen 800 MG Oral TabletPSNba86e936-ef72-43e5-aebf-f2c788fe226629
197805ibuprofen 400 MG Oral TabletSCDba86e936-ef72-43e5-aebf-f2c788fe226629
197806ibuprofen 600 MG Oral TabletSCDba86e936-ef72-43e5-aebf-f2c788fe226629
197807ibuprofen 800 MG Oral TabletSCDba86e936-ef72-43e5-aebf-f2c788fe226629
197805ibuprofen 400 MG Oral TabletPSN8ea0e303-3967-4d71-8255-ac42a841ce2825
197806ibuprofen 600 MG Oral TabletPSN8ea0e303-3967-4d71-8255-ac42a841ce2825
197807ibuprofen 800 MG Oral TabletPSN8ea0e303-3967-4d71-8255-ac42a841ce2825
197805ibuprofen 400 MG Oral TabletSCD8ea0e303-3967-4d71-8255-ac42a841ce2825
197806ibuprofen 600 MG Oral TabletSCD8ea0e303-3967-4d71-8255-ac42a841ce2825
197807ibuprofen 800 MG Oral TabletSCD8ea0e303-3967-4d71-8255-ac42a841ce2825
197805ibuprofen 400 MG Oral TabletPSN03b45386-a802-40b1-b820-0c48d6d9f8ba3
197805ibuprofen 400 MG Oral TabletSCD03b45386-a802-40b1-b820-0c48d6d9f8ba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5853-4000904585340500 TABLET in 1 BOTTLE (0904-5853-40) 500 tablet2009-06-100000-00-00NoNoCurrent
0904-5853-6000904585360100 TABLET in 1 BOTTLE (0904-5853-60) 100 tablet2009-06-100000-00-00NoNoCurrent
0904-5853-6100904585361100 BLISTER PACK in 1 CARTON (0904-5853-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2009-06-100000-00-00NoNoCurrent