IBUPROFEN

Product NDC
59105-002
11-digit product format
591050002
Labeler code
59105
Product ID
59105-002_ab71fcc6-f102-4f69-9260-6502790cf34e
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
J.P BUSINESS ENTERPRISE
Application
ANDA079205
Marketing category
ANDA
Marketing start
2013-08-20
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59105-002IInactivated by FDA2026-08-07
excluded packagepackage59105-00259105-002-10IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59105-002-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59105-002-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59105-002-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59105-002-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59105-002-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59105-002-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59105-002-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59105-002-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59105-002-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59105-002-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59105-002-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59105-002-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59105-002-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59105-002-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59105-002-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59105-002-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59105-002-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59105-002-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59105-002-108dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59105-002-10e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59105-002-109bebd1f3094a…5416666fcb17…

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
A079205-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26cb3db0bc1861…

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
59105-002-102020-01-31C16284748780-19d75b9cf-e76b-f424-e053-dadaa90a57ceIBUPROFEN softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59105-002-10IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED11
59105-002-10IBUPROFEN10 in 1 BOTTLECAPSULE, LIQUID FILLED101

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59105-002IBUPROFEN CAPSULE, LIQUID FILLED [J.P BUSINESS ENTERPRISE]1Legacy NDC, 2 package rows20130822_5217f323-8847-425f-95b7-eecc84e558b1.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
Ibuprofen MinisIBUPROFENGrocery Outlet, Inc.44665e3d-37a7-a1a7-e063-6294a90ab3762026-03-04WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENWALGREENS40a1e525-fb1e-08f4-e063-6294a90adfa72026-01-14WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCe0a8315a-80a5-4be3-aad1-3d01f00df4942025-12-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANY3802ebc9-83ca-602a-e063-6294a90a11c82025-11-20WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENBJWC (Berkley & Jensen / BJ's)2f322afb-bfc8-9dab-e063-6394a90a08b52025-08-19WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENFSA STORE INC.ec6b1b86-46fc-7e82-e053-2a95a90ac1472025-08-12WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENMARC GLASSMAN, INC.7f366669-9d31-46c7-932d-02fa64b11f302025-07-15WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI37eaa3b1-98e9-4fcf-ae74-153bfc35551f2025-07-01WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLC2810122e-3c89-49a2-8dac-db3714cb7b452024-12-30WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENWinco Foods, LLC61cd9140-eded-4bcf-894b-a163fa5f3e102024-12-06WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
PROPRINALIBUPROFEN CAPSULES 200 MGHART Healthec27b625-a3fa-4c5f-8134-c9373c09b3e32024-12-04WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb619068-be71-7569-e053-2a95a90a4a6e2024-10-26WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENKroger Companybc178013-ab2e-04f5-e053-2995a90a1ed42024-04-13WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENKROGER COMPANY0fbe42d0-b5f0-0780-e063-6394a90a4ecb2024-04-13WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENWALGREENS3ce5b71b-f841-444f-bf66-023e4bd9aa162024-03-15WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
PROPRINALIBUPROFEN CAPSULES 200 MGA-S Medication Solutions4723dd14-5d20-4a9a-b127-4237d5db59562024-01-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENTARGET CORPORATION8e8646fe-fd62-1662-e053-2a95a90a30082024-01-03WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
Ibuprofen MiniIBUPROFEN MINI 200 MGTARGET CORPORATIONc80426d9-e121-c24d-e053-2a95a90acf2f2024-01-03WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENTIME CAP LABORATORIES, INC.059cb22f-f6db-5d03-e063-6294a90a9ec12023-10-27WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN5217f323-8847-425f-95b7-eecc84e558b11
310964ibuprofen 200 MG Oral CapsuleSCD5217f323-8847-425f-95b7-eecc84e558b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59105-002-10591050002101 in 1 CARTONHistorical