FDA.reportPublic FDA data

Ibuprofen

Product NDC
53345-059
11-digit product format
533450059
Labeler code
53345
Product ID
53345-059_46a9387e-0883-f8cd-e063-6294a90af8c4
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Application
ANDA206568
Marketing category
ANDA
Marketing start
2025-12-28
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206568-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310964Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46a9424c-fd7d-f88b-e063-6294a90abcebAvailable 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
53345-059-01Ibuprofen12000 in 1 BAGCAPSULE, LIQUID FILLED120001
53345-059-01Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED11

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen minisIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2b9e71c5-9b32-4b1b-a479-e5457a1f9afd2023-10-16WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENStrategic Sourcing Services LLC9f020645-ba77-49e1-b9f1-0e36cdf26adb2023-10-05WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENBest Choice (Valu Merchandisers Company)04b4ed2b-5f43-4151-b355-ca1bb469658d2023-08-31WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENCare One (Retail Business Services, LLC.)b5e9bd39-d2c5-4a6c-b0da-8e41d633b31c2023-08-24WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENStrategic Sourcing Services LLCc363c80f-364a-4047-a246-a1fdeb98a4f02023-08-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)759e5cf4-641f-4b3c-bc06-9ee0b4d010fc2023-03-16WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)c3f1b721-2bb0-4297-bfc6-7faaf9ba84192023-03-09WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENWalgreens6bd8a0c2-314f-47cb-80cd-1d4dd92b209f2022-11-29WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENCare One (American Sales Company)016299ef-ad40-46fd-acfc-e74ffee3d9b42022-11-21WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8de40427-1be3-4a86-bc4c-9659ebaa203f2022-11-07WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENPURACAP PHARMACEUTICAL LLC9e86b6e5-5374-4699-a0d1-a4c3d069f2622020-01-17WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC73eb763e-ce21-4cff-854f-3297f20f1f612019-12-10WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC40501966-419a-4ccd-b7c9-5581cbe47a972019-12-10WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENPuraCap Pharmaceutical LLCb6e14f73-1f19-4cfa-8858-136a38ee32d02019-12-10WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC67e09ad5-e010-4aa1-b86e-9b22331bf33b2019-12-10WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC24ef6819-f098-4d01-bfe7-6ffa4aa0e6712019-12-10WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd50bab3b2-f710-46ff-96cd-1ec4d46585292019-11-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdf42506f7-896c-47a9-a4b1-ed72434d7aa02019-11-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd58bff8bf-5a4e-4390-9c03-e266d31deb6b2019-11-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltddaf579dc-91d1-4950-b637-c1a34f5542c52019-11-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN46a9424c-fd7d-f88b-e063-6294a90abceb1
310964ibuprofen 200 MG Oral CapsuleSCD46a9424c-fd7d-f88b-e063-6294a90abceb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53345-059-01533450059011 BAG in 1 CARTON (53345-059-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2025-12-28NoNoCurrent