Ibuprofen

Product NDC
50090-2809
11-digit product format
500902809
Labeler code
50090
Product ID
50090-2809_dc8822b4-a295-44fd-9ad8-f9498ecaa3dc
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075139
Marketing category
ANDA
Marketing start
1999-03-01
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 productproduct50090-2809DDiscontinued by firm2026-08-03
excluded packagepackage50090-280950090-2809-0DDiscontinued by firm2026-08-03

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2809-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2809-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2809-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2809-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2809-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2809-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2809-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2809-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2809-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2809-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2809-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2809-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-2809-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-2809-0IInactivated by FDA9bebd1f3094a…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
A075139-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1999-03-01

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 UTC2026-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013f01610625f2…
2019-09-15 20:21 UTC2019-09A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2809-02021-12-09C16284748780-19d75b9d0-8f20-f424-e053-dadaa90a57ceMajor 44-438
50090-2809-02020-01-31C16284748780-19d75b9d0-8f20-f424-e053-dadaa90a57ceMajor 44-438

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2809-0EA - Each50090-280956711a28-1810-4d89-8d50-b194176c135012018-09-05

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 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENBetter Living Brands, LLC45520969-7a2d-4469-ba25-7db160d50ccf2026-07-06WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.027ded51-aa01-6619-3938-c8162a421cf32026-06-18WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENCardinal Health 110, LLC. DBA Leadera41a0bc2-ef7a-44cd-a42e-aefab41323cc2026-06-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE01f8fe3a-8810-4b38-8860-d95e05d377092026-06-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENCardinal Health 107, LLC260f5862-d65d-4c34-bf53-26ca30806a672026-05-19WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENMeijer Distribution, Inc.3e3a5366-535d-45fb-81af-c7d98ac20b112026-05-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Ibuprofen Dye FreeIBUPROFENCVS Pharmacy00653b7c-7099-487e-9a01-e89781c213232026-04-29WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENMeijer Distribution Inc36f7227d-f3cb-44b7-a4c1-27611cd150522026-04-24WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENRite Aid Corporation72e11f2d-a348-4c12-9cd8-1e6f0f6f73992026-04-09WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Ibuprofen Dye-FreeIBUPROFENWal-Mart Stores Inc23cb5001-6aeb-434a-b2e8-aaf8bbab9dc62026-04-01WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Ibuprofen Dye FreeIBUPROFENWALMART INC.2b04d255-a1df-4698-9b5a-ad7a12205e1b2026-03-25WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
pain relief ibuprofenIBUPROFENRite Aid Corporation2bd1438e-27b1-81ff-f8e1-0f5b50b045812026-02-02WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENH E B88c7486b-f9a7-4856-a25a-7c06e1382f1a2026-02-02WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.82e907e6-86a9-5c7f-93bd-a6319d74100f2026-01-13WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.8ebe3e16-b7ae-d333-6671-5bc935e259002026-01-13WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.c93da67f-f42e-4baa-976b-73c71ba6dd712026-01-12WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENMajor Pharmaceuticals6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f62025-12-17WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Dye Free IbuprofenIBUPROFENWalgreen Companyd3d093f9-207a-40d4-a7be-c6b5a544a0a72025-12-12WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENFamily Dollar Services Inc89ed9311-2185-4660-b219-9ea67b1a71ec2025-11-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENTopco Associates, LLCbcf7d4c1-1f99-48df-8f74-9abeefa8d41d2025-11-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139