FDA.reportPublic FDA data

IBUPAK

Product NDC
59088-756
11-digit product format
590880756
Labeler code
59088
Product ID
59088-756_f2051c68-cdec-58b2-e053-2995a90a6b48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
KIT
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-05-22
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBUPAK
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197806Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a63f3857-92d1-0adf-e053-2995a90a3afaAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-756-00IBUPAK1 in 1 KITKIT13
67877-320-01IBUPAK100 in 1 BOTTLETABLET, FILM COATED100600 mg3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-756IBUPAK (IBUPROFEN) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC, 2 package rows20230112_a63f3857-92d1-0adf-e053-2995a90a3afa.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPAKIBUPROFENPureTek Corporationa63f3857-92d1-0adf-e053-2995a90a3afa2023-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 59088-756

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNa63f3857-92d1-0adf-e053-2995a90a3afa3
197806ibuprofen 600 MG Oral TabletSCDa63f3857-92d1-0adf-e053-2995a90a3afa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-756-00590880756001 KIT in 1 KIT (59088-756-00) * 100 TABLET, FILM COATED in 1 BOTTLE (67877-320-01) 1 kit2020-05-220000-00-00NoNoCurrent
67877-320-0167877032001100 in 1 BOTTLEHistorical