FDA.reportPublic FDA data

Ibuprofen

Product NDC
72865-132
11-digit product format
728650132
Labeler code
72865
Product ID
72865-132_0de44491-e307-43f6-8629-024173bc7d5d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL; ORAL
Labeler
XLCare Pharmaceuticals, Inc
Application
ANDA206999
Marketing category
ANDA
Marketing start
2020-03-09
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

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72865-132IInactivated by FDA2026-07-31
excluded packagepackage72865-13272865-132-16IInactivated by FDA2026-07-31
excluded packagepackage72865-13272865-132-20IInactivated by FDA2026-07-31
excluded packagepackage72865-13272865-132-40IInactivated by FDA2026-07-31
excluded packagepackage72865-13272865-132-80IInactivated by FDA2026-07-31

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
72865-132-162022-01-28C16284748780-1d6a99b39-54b6-a426-e053-dadaa90af4c28fbc30d3-149d-4369-aaf4-6019cff9760d
72865-132-202022-01-28C16284748780-1d6a99b39-54b6-a426-e053-dadaa90af4c28fbc30d3-149d-4369-aaf4-6019cff9760d
72865-132-402022-01-28C16284748780-1d6a99b39-54b6-a426-e053-dadaa90af4c28fbc30d3-149d-4369-aaf4-6019cff9760d
72865-132-802022-01-28C16284748780-1d6a99b39-54b6-a426-e053-dadaa90af4c28fbc30d3-149d-4369-aaf4-6019cff9760d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-132-16Ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1601
72865-132-20Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED201
72865-132-40Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED401
72865-132-80Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-132-16EA - Each72865-132f8cfb3bd-e6d6-4157-a1f1-abff0252e11d12020-06-05
72865-132-20EA - Each72865-1324da477fd-c03c-4308-9176-203da84f989612020-06-05
72865-132-40EA - Each72865-132e7053a71-3665-4903-a6b7-37495932100912020-06-05
72865-132-80EA - Each72865-1326e106ad5-93f2-4de1-8990-4e48078d90c012020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-132IBUPROFEN CAPSULE, LIQUID FILLED [XLCARE PHARMACEUTICALS, INC]1Legacy NDC, 4 package rows20200415_8fbc30d3-149d-4369-aaf4-6019cff9760d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN8fbc30d3-149d-4369-aaf4-6019cff9760d1
310964ibuprofen 200 MG Oral CapsuleSCD8fbc30d3-149d-4369-aaf4-6019cff9760d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-132-1672865013216160 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-132-16) 2020-03-090000-00-00NoNoCurrent
72865-132-207286501322020 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-132-20) 2020-03-090000-00-00NoNoCurrent
72865-132-407286501324040 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-132-40) 2020-03-090000-00-00NoNoCurrent
72865-132-807286501328080 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-132-80) 2020-03-090000-00-00NoNoCurrent