FDA.reportPublic FDA data

Ibuprofen

Product NDC
53746-137
11-digit product format
537460137
Labeler code
53746
Product ID
53746-137_32dbe366-3f8b-4ace-9ce4-a9b695c58d30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA071935
Marketing category
ANDA
Marketing start
2009-01-05
Substance
IBUPROFEN
Active strength
800 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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
53746-137-012021-03-18C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-052021-03-18C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-302021-03-18C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-502021-03-18C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-602021-03-18C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-902021-03-18C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-012021-01-29C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-052021-01-29C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-302021-01-29C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-502021-01-29C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-602021-01-29C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP
53746-137-902021-01-29C16284748780-1ba0f9c33-3ba3-a910-e053-dadaa90a0b85IBUPROFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-137-01Ibuprofen100 in 1 BOTTLETABLET10016
53746-137-05Ibuprofen500 in 1 BOTTLETABLET50016
53746-137-30Ibuprofen30 in 1 BOTTLETABLET3016
53746-137-50Ibuprofen50 in 1 BOTTLETABLET5016
53746-137-60Ibuprofen60 in 1 BOTTLETABLET6016
53746-137-90Ibuprofen90 in 1 BOTTLETABLET9016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-137IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]16Current NDC, Legacy NDC, 6 package rows20241222_75d963b9-3675-44ff-bc6b-83461bed1b67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN75d963b9-3675-44ff-bc6b-83461bed1b6716
197807ibuprofen 800 MG Oral TabletSCD75d963b9-3675-44ff-bc6b-83461bed1b6716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-137-0153746013701100 TABLET in 1 BOTTLE (53746-137-01) 100 tablet2009-01-050000-00-00NoNoCurrent
53746-137-0553746013705500 TABLET in 1 BOTTLE (53746-137-05) 500 tablet2009-01-050000-00-00NoNoCurrent
53746-137-305374601373030 TABLET in 1 BOTTLE (53746-137-30) 30 tablet2009-01-050000-00-00NoNoCurrent
53746-137-505374601375050 TABLET in 1 BOTTLE (53746-137-50) 50 tablet2009-01-050000-00-00NoNoCurrent
53746-137-605374601376060 TABLET in 1 BOTTLE (53746-137-60) 60 tablet2009-01-050000-00-00NoNoCurrent
53746-137-905374601379090 TABLET in 1 BOTTLE (53746-137-90) 90 tablet2009-01-050000-00-00NoNoCurrent