FDA.reportPublic FDA data

Ibuprofen

Product NDC
25000-117
11-digit product format
250000117
Labeler code
25000
Product ID
25000-117_1bdc2c02-575f-4b55-ad66-47108f628d18
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA091239
Marketing category
ANDA
Marketing start
2011-07-25
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
25000-117-02Ibuprofen1 in 1 CARTONTABLET18
25000-117-02Ibuprofen24 in 1 BOTTLETABLET248
25000-117-03Ibuprofen30 in 1 BOTTLETABLET308
25000-117-14Ibuprofen1000 in 1 BOTTLETABLET10008
25000-117-20Ibuprofen4 in 1 BOXTABLET48
25000-117-20Ibuprofen6500 in 1 BAGTABLET65008
25000-117-30Ibuprofen6500 in 1 BAGTABLET65008
25000-117-30Ibuprofen6 in 1 BOXTABLET68
25000-117-69Ibuprofen300 in 1 BOTTLETABLET3008
25000-117-93Ibuprofen1 in 1 BOXTABLET18
25000-117-93Ibuprofen37470 in 1 BAGTABLET374708
25000-117-98Ibuprofen34065 in 1 BAGTABLET340658
25000-117-98Ibuprofen1 in 1 BOXTABLET18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-117IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]8Current NDC, Legacy NDC, 13 package rows20211230_3c8df1e5-61bc-4e70-b6b9-8973986ad589.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN3c8df1e5-61bc-4e70-b6b9-8973986ad5898
310965ibuprofen 200 MG Oral TabletSCD3c8df1e5-61bc-4e70-b6b9-8973986ad5898
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY3c8df1e5-61bc-4e70-b6b9-8973986ad5898

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-117-02250000117021 BOTTLE in 1 CARTON (25000-117-02) / 24 TABLET in 1 BOTTLE1 bottle2019-12-200000-00-00NoNoCurrent
25000-117-032500001170330 TABLET in 1 BOTTLE (25000-117-03) 30 tablet2011-07-250000-00-00NoNoCurrent
25000-117-14250000117141000 TABLET in 1 BOTTLE (25000-117-14) 1000 tablet2011-07-250000-00-00NoNoCurrent
25000-117-20250000117204 BAG in 1 BOX (25000-117-20) / 6500 TABLET in 1 BAG4 bag2011-07-250000-00-00NoNoCurrent
25000-117-30250000117306 BAG in 1 BOX (25000-117-30) / 6500 TABLET in 1 BAG6 bag2011-07-250000-00-00NoNoCurrent
25000-117-6925000011769300 TABLET in 1 BOTTLE (25000-117-69) 300 tablet2011-07-250000-00-00NoNoCurrent
25000-117-93250000117931 BAG in 1 BOX (25000-117-93) / 37470 TABLET in 1 BAG1 bag2011-07-250000-00-00NoNoCurrent
25000-117-98250000117981 BAG in 1 BOX (25000-117-98) / 34065 TABLET in 1 BAG1 bag2011-07-250000-00-00NoNoCurrent