Ibuprofen

Product NDC
55154-1342
11-digit product format
551541342
Labeler code
55154
Product ID
55154-1342_67b40848-5ab6-4365-8281-6cfc0e01da9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA075682
Marketing category
ANDA
Marketing start
2009-06-10
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
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
55154-1342-0Ibuprofen10 in 1 BAGTABLET, FILM COATED1025
55154-1342-0Ibuprofen1 in 1 BLISTER PACKTABLET, FILM COATED125

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
55154-1342IBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]24Current NDC, Legacy NDC, 2 package rows20250410_8ea0e303-3967-4d71-8255-ac42a841ce28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-1342-05515413420010 BLISTER PACK in 1 BAG (55154-1342-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2009-06-100000-00-00NoNoCurrent