FDA.reportPublic FDA data

Ibuprofen

Product NDC
53746-140
11-digit product format
537460140
Labeler code
53746
Product ID
53746-140_e2b9bf54-0449-4f9b-86e8-e3b292387dd5
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA071333
Marketing category
ANDA
Marketing start
2009-12-16
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
Brand name suffix
Pain Releiver/ Fever Reducer
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53746-140-012021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-102021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-242021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-012021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-102021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-242021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-140-01IbuprofenPain Releiver/ Fever Reducer100 in 1 BOTTLETABLET10016
53746-140-10IbuprofenPain Releiver/ Fever Reducer1000 in 1 BOTTLETABLET100016
53746-140-24IbuprofenPain Releiver/ Fever Reducer24 in 1 BOTTLETABLET2416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-140-01EA - Each53746-1409b59909e-f012-4650-b0bb-48b24756969612013-02-11
53746-140-10EA - Each53746-140ec68f427-dec6-4174-929c-cfc07f475edc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
POVIDONESINACTIVE INGREDIENTFZ989GH94EIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-140IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]16Current NDC, Legacy NDC, 3 package rows20240101_ee241be0-35f8-4789-a71f-98de31d6a590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNee241be0-35f8-4789-a71f-98de31d6a59016
310965ibuprofen 200 MG Oral TabletSCDee241be0-35f8-4789-a71f-98de31d6a59016
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYee241be0-35f8-4789-a71f-98de31d6a59016
310965ibuprofen 200 MG Oral TabletPSN7b4858fc-fea6-4e4c-886e-a2febe1ed2c31
310965ibuprofen 200 MG Oral TabletSCD7b4858fc-fea6-4e4c-886e-a2febe1ed2c31
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY7b4858fc-fea6-4e4c-886e-a2febe1ed2c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-140-0153746014001100 TABLET in 1 BOTTLE (53746-140-01) 100 tablet2009-12-160000-00-00NoNoCurrent
53746-140-10537460140101000 TABLET in 1 BOTTLE (53746-140-10) 1000 tablet2009-12-160000-00-00NoNoCurrent
53746-140-245374601402424 TABLET in 1 BOTTLE (53746-140-24) 24 tablet2009-12-160000-00-00NoNoCurrent