Ibuprofen

Product NDC
11673-249
11-digit product format
116730249
Labeler code
11673
Product ID
11673-249_1a09bb11-7cfb-46c4-aa33-71e8d1b7c29b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TARGET Corporation
Application
ANDA079174
Marketing category
ANDA
Marketing start
2014-03-28
Marketing end
2020-12-31
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct11673-249DDiscontinued by firm2026-08-17
excluded packagepackage11673-24911673-249-50DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage11673-249-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11673-249-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11673-249-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11673-249-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11673-249-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11673-249-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11673-249-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11673-249-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11673-249-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11673-249-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11673-249-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-249-50557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A079174-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2010-12-10

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10e64feba35796…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, COATED [TARGET CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, COATED [TARGET CORPORATION]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, COATED [TARGET CORPORATION]1
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUPROFEN TABLET, COATED [TARGET CORPORATION]1

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 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-08-06WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Ibuwin ForteIBUPROFENOPMX LLC0daf1be9-ea38-461e-e063-6394a90a79542026-07-15WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENDr. Reddy's Laboratories Inc.4d830b9b-b396-9581-7572-c7f19ff175972026-07-01WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.68988a5b-7a6a-4ecd-8006-f2610bac2ad72026-06-08WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENMedline industries, LP5d2482b4-cd90-4246-85a9-fd1d35315b6c2026-06-04WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENGrocery Outlet, Inc.441d762d-9022-426a-e063-6294a90a50762026-05-21WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IBUPROFEN 200 MGIBUPROFEN 200 MGFarmacias De Similares TX LLC441f7920-5666-5a3e-e063-6294a90a55832026-01-28WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHYVEE INC45aead8a-37ee-9a66-e063-6394a90a5d172026-01-13WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Xpect IbuprofenIBUPROFENCintas Corporation976ba88a-6428-40d1-a2fd-eac64963ba1d2026-01-08WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Inc29190ebf-bb9c-4406-be7b-4427741aeb742025-12-23WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENCVS10424ad8-74fc-4f5f-e063-6394a90a13bd2025-12-23WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENGranules USA, Inc.8cb595d2-b7c2-687d-e053-2a95a90a57202025-12-22WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRetail Business Services, LLC04115ec1-ef31-1746-e063-6394a90a0a522025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a567dc6f-bd83-b9f5-e053-2995a90a05ee2025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c17f-9766-deaa-e063-6394a90a8d602025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IBUPROFENIBUPROFENWALGREENS CO.b8a77b7e-e161-b3ac-e053-2995a90af3e82025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENFamily Dollarfe17f5a6-fd6d-d839-e053-6394a90a59a42025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174