Ibuprofen

Product NDC
25000-122
11-digit product format
250000122
Labeler code
25000
Product ID
25000-122_06380458-ba55-458e-b6f8-e6219af48f32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA090796
Marketing category
ANDA
Marketing start
2011-02-28
Substance
IBUPROFEN
Active strength
600 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
IBUPROFEN600 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
25000-122-03Ibuprofen30 in 1 BOTTLETABLET3015
25000-122-12Ibuprofen500 in 1 BOTTLETABLET50015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-122IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]15Current NDC, Legacy NDC, 2 package rows20241023_e54209c2-f726-440b-ac60-5a72710d2a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNe54209c2-f726-440b-ac60-5a72710d2a9b15
197806ibuprofen 600 MG Oral TabletPSNe54209c2-f726-440b-ac60-5a72710d2a9b15
197807ibuprofen 800 MG Oral TabletPSNe54209c2-f726-440b-ac60-5a72710d2a9b15
197805ibuprofen 400 MG Oral TabletSCDe54209c2-f726-440b-ac60-5a72710d2a9b15
197806ibuprofen 600 MG Oral TabletSCDe54209c2-f726-440b-ac60-5a72710d2a9b15
197807ibuprofen 800 MG Oral TabletSCDe54209c2-f726-440b-ac60-5a72710d2a9b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-122-032500001220330 TABLET in 1 BOTTLE (25000-122-03) 30 tablet2011-02-280000-00-00NoNoCurrent
25000-122-1225000012212500 TABLET in 1 BOTTLE (25000-122-12) 500 tablet2011-02-280000-00-00NoNoCurrent
25000-122-18250000122184 BAG in 1 BOX (25000-122-18) > 2500 TABLET in 1 BAG4 bag2011-02-280000-00-00NoNoCurrent
25000-122-28250000122286 BAG in 1 BOX (25000-122-28) > 2500 TABLET in 1 BAG6 bag2011-02-280000-00-00NoNoCurrent
25000-122-93250000122931 BAG in 1 BOX (25000-122-93) > 12490 TABLET in 1 BAG1 bag2011-02-280000-00-00NoNoCurrent
25000-122-98250000122981 BAG in 1 BOX (25000-122-98) > 11355 TABLET in 1 BAG1 bag2011-02-280000-00-00NoNoCurrent