FDA.reportPublic FDA data

Ibuprofen

Product NDC
55319-398
11-digit product format
553190398
Labeler code
55319
Product ID
55319-398_b7b4d9ae-0bc3-9df4-e053-2995a90a4ede
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
FAMILY DOLLAR
Application
ANDA202312
Marketing category
ANDA
Marketing start
2020-01-31
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
55319-398-102023-01-30C16284748780-1ab0e2407-2995-f274-e053-dbdaa90a6471Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
55319-398-102020-12-30C16284748780-1ab0e2407-2995-f274-e053-dbdaa90a6471Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
55319-398-102020-09-27C16284748780-1ab0e2407-2995-f274-e053-dbdaa90a6471Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
55319-398-102020-09-25C16284748780-1ab0e2407-2995-f274-e053-dbdaa90a6471Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
55319-398-102020-07-22C16284748780-1ab0e2407-2995-f274-e053-dbdaa90a6471Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-398-10Ibuprofen100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-398IBUPROFEN TABLET [FAMILY DOLLAR]2Legacy NDC, 1 package rows20201231_97666c24-969f-9e76-e053-2a95a90a4432.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN97666c24-969f-9e76-e053-2a95a90a44322
310965ibuprofen 200 MG Oral TabletSCD97666c24-969f-9e76-e053-2a95a90a44322
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY97666c24-969f-9e76-e053-2a95a90a44322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-398-1055319039810100 TABLET in 1 BOTTLE (55319-398-10) 100 tablet2020-01-310000-00-00NoNoCurrent