FDA.reportPublic FDA data

ibuprofen

Product NDC
0904-7912
11-digit product format
009047912
Labeler code
0904
Product ID
0904-7912_87be94e4-0b11-4947-9a25-5c02750f7489
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA072096
Marketing category
ANDA
Marketing start
1994-08-16
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
0904-7912-24ibuprofen24 in 1 BOTTLETABLET, FILM COATED249
0904-7912-24ibuprofen1 in 1 CARTONTABLET, FILM COATED19
0904-7912-51ibuprofen50 in 1 BOTTLETABLET, FILM COATED509
0904-7912-51ibuprofen1 in 1 CARTONTABLET, FILM COATED19
0904-7912-59ibuprofen1 in 1 CARTONTABLET, FILM COATED19
0904-7912-59ibuprofen100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7912-24EA - Each0904-7912ec60efa7-0c06-43e7-8911-c8b02f7d2f7112013-12-02
0904-7912-51EA - Each0904-79128bdfcdc9-7024-457f-aaa6-c2919ddd129c12012-07-24
0904-7912-59EA - Each0904-79129e0a1d87-95f0-4f7d-b444-64dd518bb4eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, COATED [MAJOR PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7912IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 6 package rows20241208_03993008-7bd2-465f-b5a9-1cbc3c1fff02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN230fd746-92e0-40b6-9a90-595812bd8a18102
310965ibuprofen 200 MG Oral TabletSCD230fd746-92e0-40b6-9a90-595812bd8a18102
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY230fd746-92e0-40b6-9a90-595812bd8a18102
310965ibuprofen 200 MG Oral TabletPSN03993008-7bd2-465f-b5a9-1cbc3c1fff029
310965ibuprofen 200 MG Oral TabletSCD03993008-7bd2-465f-b5a9-1cbc3c1fff029
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY03993008-7bd2-465f-b5a9-1cbc3c1fff029
310965ibuprofen 200 MG Oral TabletPSN4ee828df-873d-4379-9a17-a805d97dfe041
310965ibuprofen 200 MG Oral TabletPSNdbda873b-4bb7-837e-e053-2a95a90a5e2f1
310965ibuprofen 200 MG Oral TabletSCD4ee828df-873d-4379-9a17-a805d97dfe041
310965ibuprofen 200 MG Oral TabletSCDdbda873b-4bb7-837e-e053-2a95a90a5e2f1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4ee828df-873d-4379-9a17-a805d97dfe041
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYdbda873b-4bb7-837e-e053-2a95a90a5e2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7912-240090479122424 in 1 BOTTLEHistorical
0904-7912-51009047912511 BOTTLE in 1 CARTON (0904-7912-51) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1994-08-160000-00-00NoNoCurrent
0904-7912-59009047912591 BOTTLE in 1 CARTON (0904-7912-59) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1994-08-300000-00-00NoNoCurrent