FDA.reportPublic FDA data

Ibuprofen

Product NDC
25000-136
11-digit product format
250000136
Labeler code
25000
Product ID
25000-136_e0bdfb43-8e4d-4ff4-9642-f3bd460b8465
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA091237
Marketing category
ANDA
Marketing start
2015-11-06
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-136-02Ibuprofen1 in 1 CARTONTABLET17
25000-136-02Ibuprofen24 in 1 BOTTLETABLET247
25000-136-03Ibuprofen30 in 1 BOTTLETABLET307
25000-136-14Ibuprofen1000 in 1 BOTTLETABLET10007
25000-136-30Ibuprofen6500 in 1 BAGTABLET65007
25000-136-30Ibuprofen6 in 1 BOXTABLET67
25000-136-69Ibuprofen300 in 1 BOTTLETABLET3007
25000-136-71Ibuprofen1000 in 1 BOTTLETABLET10007
25000-136-93Ibuprofen1 in 1 BOXTABLET17
25000-136-93Ibuprofen37470 in 1 BAGTABLET374707
25000-136-98Ibuprofen34065 in 1 BAGTABLET340657
25000-136-98Ibuprofen1 in 1 BOXTABLET17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-136IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]7Current NDC, Legacy NDC, 12 package rows20211230_859d7190-586f-4766-a7e7-9e800a72d58b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN859d7190-586f-4766-a7e7-9e800a72d58b7
310965ibuprofen 200 MG Oral TabletSCD859d7190-586f-4766-a7e7-9e800a72d58b7
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY859d7190-586f-4766-a7e7-9e800a72d58b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-136-02250000136021 BOTTLE in 1 CARTON (25000-136-02) / 24 TABLET in 1 BOTTLE1 bottle2019-12-200000-00-00NoNoCurrent
25000-136-032500001360330 TABLET in 1 BOTTLE (25000-136-03) 30 tablet2015-11-060000-00-00NoNoCurrent
25000-136-14250000136141000 TABLET in 1 BOTTLE (25000-136-14) 1000 tablet2015-11-060000-00-00NoNoCurrent
25000-136-30250000136306 BAG in 1 BOX (25000-136-30) / 6500 TABLET in 1 BAG6 bag2015-11-060000-00-00NoNoCurrent
25000-136-6925000013669300 TABLET in 1 BOTTLE (25000-136-69) 300 tablet2015-11-060000-00-00NoNoCurrent
25000-136-71250000136711000 TABLET in 1 BOTTLE (25000-136-71) 1000 tablet2015-11-060000-00-00NoNoCurrent
25000-136-93250000136931 BAG in 1 BOX (25000-136-93) / 37470 TABLET in 1 BAG1 bag2015-11-060000-00-00NoNoCurrent
25000-136-98250000136981 BAG in 1 BOX (25000-136-98) / 34065 TABLET in 1 BAG1 bag2015-11-060000-00-00NoNoCurrent