FDA.reportPublic FDA data

Ibuprofen

Product NDC
53746-132
11-digit product format
537460132
Labeler code
53746
Product ID
53746-132_fc9fc973-31c3-42df-93e7-eeeeb280bcaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA071335
Marketing category
ANDA
Marketing start
2009-01-05
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
Rxcui197806

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
53746-132-012021-03-18C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-052021-03-18C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-302021-03-18C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-502021-03-18C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-602021-03-18C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-902021-03-18C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-012021-01-29C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-052021-01-29C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-302021-01-29C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-502021-01-29C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-602021-01-29C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-132-902021-01-29C16284748780-1ba0f9c33-313b-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-132-01Ibuprofen100 in 1 BOTTLETABLET10014
53746-132-05Ibuprofen500 in 1 BOTTLETABLET50014
53746-132-30Ibuprofen30 in 1 BOTTLETABLET3014
53746-132-50Ibuprofen50 in 1 BOTTLETABLET5014
53746-132-60Ibuprofen60 in 1 BOTTLETABLET6014
53746-132-90Ibuprofen90 in 1 BOTTLETABLET9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-132IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]14Current NDC, Legacy NDC, 6 package rows20241222_8df77ead-27eb-4f6f-95a9-f68d3e9cfa71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN8df77ead-27eb-4f6f-95a9-f68d3e9cfa7114
197806ibuprofen 600 MG Oral TabletSCD8df77ead-27eb-4f6f-95a9-f68d3e9cfa7114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-132-0153746013201100 TABLET in 1 BOTTLE (53746-132-01) 100 tablet2009-01-050000-00-00NoNoCurrent
53746-132-0553746013205500 TABLET in 1 BOTTLE (53746-132-05) 500 tablet2009-01-050000-00-00NoNoCurrent
53746-132-305374601323030 TABLET in 1 BOTTLE (53746-132-30) 30 tablet2009-01-050000-00-00NoNoCurrent
53746-132-505374601325050 TABLET in 1 BOTTLE (53746-132-50) 50 tablet2009-01-050000-00-00NoNoCurrent
53746-132-605374601326060 TABLET in 1 BOTTLE (53746-132-60) 60 tablet2009-01-050000-00-00NoNoCurrent
53746-132-905374601329090 TABLET in 1 BOTTLE (53746-132-90) 90 tablet2009-01-050000-00-00NoNoCurrent