FDA.reportPublic FDA data

Ibuprofen

Product NDC
50594-146
Requested package NDC
50594-146-04
11-digit product format
505940146
Labeler code
50594
Product ID
50594-146_b7b4f650-ec1a-9f62-e053-2995a90aa17a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
BIG LOTS STORES, INC.
Application
ANDA206999
Marketing category
ANDA
Marketing start
2019-04-30
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/2001
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50594-14650594-146-04IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206999-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENRite Aid Corporation47657d95-4a54-49c2-8273-86b413b8f41e2025-07-30WarningsExact identifier
application applno (ANDA): 206999
application number: ANDA206999
Dolex FlexIBUPROFENPharmadel LLC822d9def-504c-9beb-e053-2991aa0a280e2023-09-13WarningsExact identifier
application applno (ANDA): 206999
application number: ANDA206999
IbuprofenIBUPROFENCostco Wholesaleeb62ed66-cafd-4d09-acc9-b9abf748ba852022-10-11WarningsExact identifier
application applno (ANDA): 206999
application number: ANDA206999

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
50594-146-042022-01-28C16284748780-1d6a99b39-4ce4-a426-e053-dadaa90af4c2Ibuprofen Capsules, 200 mg Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50594-146-04Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-146IBUPROFEN CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]2Legacy NDC, 1 package rows20201231_862d926f-a6d3-31e1-e053-2991aa0a6454.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN862d926f-a6d3-31e1-e053-2991aa0a64542
310964ibuprofen 200 MG Oral CapsuleSCD862d926f-a6d3-31e1-e053-2991aa0a64542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50594-146-045059401460440 CAPSULE, LIQUID FILLED in 1 BOTTLE (50594-146-04) 2019-04-300000-00-00NoNoCurrent