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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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