Ibuprofen

Product NDC
53808-0436
11-digit product format
538080436
Labeler code
53808
Product ID
53808-0436_42aee221-dc31-493c-b420-18cdb1546968
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA071335
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
53808-0436-12019-10-21C16284748780-1956f9ecf-ce91-621f-e053-dbdaa90a74adIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0436-1Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0436IBUPROFEN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100817_5ad82932-7b26-4227-971a-09ce0bf7971c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN5ad82932-7b26-4227-971a-09ce0bf7971c1
197806ibuprofen 600 MG Oral TabletPSN5ad82932-7b26-4227-971a-09ce0bf7971c1
197807ibuprofen 800 MG Oral TabletPSN5ad82932-7b26-4227-971a-09ce0bf7971c1
197805ibuprofen 400 MG Oral TabletSCD5ad82932-7b26-4227-971a-09ce0bf7971c1
197806ibuprofen 600 MG Oral TabletSCD5ad82932-7b26-4227-971a-09ce0bf7971c1
197807ibuprofen 800 MG Oral TabletSCD5ad82932-7b26-4227-971a-09ce0bf7971c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0436-15380804360130 in 1 BLISTER PACKHistorical