IBUPROFEN

Product NDC
68210-0009
11-digit product format
682100009
Labeler code
68210
Product ID
68210-0009_ee03445d-01db-a710-e053-2995a90a57a2
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS,LLC
Application
ANDA079205
Marketing category
ANDA
Marketing start
2017-11-22
Marketing end
0000-00-00
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
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-0009DDiscontinued by firm2026-08-03
excluded packagepackage68210-000968210-0009-0DDiscontinued by firm2026-08-03
excluded packagepackage68210-000968210-0009-1DDiscontinued by firm2026-08-03
excluded packagepackage68210-000968210-0009-6DDiscontinued 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 · 48 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 packagepackage68210-0009-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68210-0009-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68210-0009-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68210-0009-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68210-0009-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68210-0009-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68210-0009-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68210-0009-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68210-0009-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68210-0009-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68210-0009-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68210-0009-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68210-0009-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68210-0009-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68210-0009-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68210-0009-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68210-0009-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68210-0009-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68210-0009-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68210-0009-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68210-0009-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68210-0009-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68210-0009-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68210-0009-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68210-0009-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68210-0009-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68210-0009-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68210-0009-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68210-0009-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68210-0009-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68210-0009-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68210-0009-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68210-0009-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68210-0009-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68210-0009-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68210-0009-1557ba5c1ecfa…9c80585c8c6e…

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 Socrata Ingredients#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0009-0682100009001 BOTTLE in 1 CARTON (68210-0009-0) > 10 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-11-220000-00-00NoNoCurrent
68210-0009-1682100009011 BOTTLE in 1 CARTON (68210-0009-1) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-11-220000-00-00NoNoCurrent
68210-0009-6682100009061 BOTTLE in 1 CARTON (68210-0009-6) > 6 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2018-10-240000-00-00NoNoCurrent