FDA.reportPublic FDA data

Ibuprofen

Product NDC
0904-7914
11-digit product format
009047914
Labeler code
0904
Product ID
0904-7914_dcd65ab9-888c-4834-a3fa-579fae91c22d
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075139
Marketing category
ANDA
Marketing start
1999-03-01
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
0904-7914-51Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5027
0904-7914-51Ibuprofen1 in 1 CARTONTABLET, FILM COATED127
0904-7914-59Ibuprofen1 in 1 CARTONTABLET, FILM COATED127
0904-7914-59Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10027
0904-7914-61Ibuprofen10 in 1 CARTONTABLET, FILM COATED1027
0904-7914-61Ibuprofen10 in 1 BLISTER PACKTABLET, FILM COATED1027
0904-7914-80Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7914-51EA - Each0904-7914faa93b86-ce5e-4cea-a618-d30548170c0112013-02-11
0904-7914-59EA - Each0904-79146207b3ed-4288-4025-95b9-9f3de378829a12013-02-11
0904-7914-61EA - Each0904-791463c8e5fc-e8e6-4891-8a01-75cb8214941912013-02-13
0904-7914-80EA - Each0904-79146bc0c001-c7a4-41d8-a354-be1952047e0a12018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [CARDINAL HEALTH]5
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [CARDINAL HEALTH]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [CARDINAL HEALTH]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [CARDINAL HEALTH]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET [CARDINAL HEALTH]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [CARDINAL HEALTH]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EIBUPROFEN TABLET [CARDINAL HEALTH]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [CARDINAL HEALTH]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET [CARDINAL HEALTH]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [CARDINAL HEALTH]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [CARDINAL HEALTH]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [CARDINAL HEALTH]5
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUPROFEN TABLET [CARDINAL HEALTH]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7914IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]25Current NDC, Legacy NDC, 7 package rows20250425_6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f627
310965ibuprofen 200 MG Oral TabletSCD6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f627
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f627
310965ibuprofen 200 MG Oral TabletPSN260f5862-d65d-4c34-bf53-26ca30806a6717
310965ibuprofen 200 MG Oral TabletSCD260f5862-d65d-4c34-bf53-26ca30806a6717
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY260f5862-d65d-4c34-bf53-26ca30806a6717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7914-51009047914511 BOTTLE in 1 CARTON (0904-7914-51) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1999-03-010000-00-00NoNoCurrent
0904-7914-59009047914591 BOTTLE, PLASTIC in 1 CARTON (0904-7914-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent
0904-7914-610090479146110 BLISTER PACK in 1 CARTON (0904-7914-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack1999-03-010000-00-00NoNoCurrent
0904-7914-80009047914801000 TABLET, FILM COATED in 1 BOTTLE (0904-7914-80) 1999-03-012021-11-26NoNoCurrent