FDA.reportPublic FDA data

ibuprofen

Product NDC
68788-7983
11-digit product format
687887983
Labeler code
68788
Product ID
68788-7983_a0381639-4e81-4db7-a0b6-5b7223387b04
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA072096
Marketing category
ANDA
Marketing start
2021-08-05
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7983DDiscontinued by firm2026-10-12
excluded packagepackage68788-798368788-7983-1DDiscontinued by firm2026-10-12
excluded packagepackage68788-798368788-7983-2DDiscontinued by firm2026-10-12
excluded packagepackage68788-798368788-7983-3DDiscontinued by firm2026-10-12
excluded packagepackage68788-798368788-7983-5DDiscontinued by firm2026-10-12

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
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7983-1EA - Each68788-7983fe81be05-2349-4c1e-99c6-dfc06b374ce412024-03-12
68788-7983-2EA - Each68788-79835319b832-7383-4484-9c81-8f856bb7e71112024-03-12
68788-7983-3EA - Each68788-7983e3eac9d0-e3b1-4b3a-99bc-55a6bd519ce912024-03-12
68788-7983-5EA - Each68788-7983bb2027b1-086a-4ab3-8daf-9e428c8f6a4612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7983IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC20240525_022a1a35-27ab-4678-85de-a03bb24b88b4.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 2 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENWalgreen Company37c9b887-190a-4daf-8199-f406913132f02025-09-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLCcfa8578c-2bcc-4aa7-bb8c-0d0e193020ed2025-08-28WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENBryant Ranch Prepack230fd746-92e0-40b6-9a90-595812bd8a182025-08-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader63b8d389-7feb-41d2-8970-b7d5660ccb4a2025-08-14WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Topcare IbuprofenIBUPROFENTopco Associates LLC8be375b0-c729-49de-abc5-2e7d37144b892025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen08d9477e-3033-4b74-8f81-934f39e37e552025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI9bf3546a-9f94-47b5-9b01-aed93e69d5aa2025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPublix Super Markets Inc032decc5-9f7a-4f12-8ca4-a95a79a426c62025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
care one ibuprofenIBUPROFENAmerican Sales Company006adf23-21ab-4a4e-aae9-c4e5877771652025-06-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMeijer Distribution Inc66b19ed1-6cf9-4705-82cd-02f23c6379e72025-05-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
kirkland signature ibuprofenIBUPROFENCostco Wholesale Company65d8d650-9afc-44f7-9409-a3aa3014d4ab2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENA-S Medication Solutions504c7e5d-e721-4df8-865b-8ea17559831d2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
up and up ibuprofenIBUPROFENTarget Corporation2919fe8b-9c76-4ef6-851e-3247782cef442025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIe18f4ce6-d7d3-4b53-b87a-5900ac3397f12025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
TopCare IbuprofenIBUPROFENTopco Associates LLC66097f19-227c-4f9c-a7f3-ab8476e1bb6e2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7983-168788798301100 TABLET, FILM COATED in 1 BOTTLE (68788-7983-1) 2021-08-050000-00-00NoNoCurrent
68788-7983-26878879830220 TABLET, FILM COATED in 1 BOTTLE (68788-7983-2) 2021-08-050000-00-00NoNoCurrent
68788-7983-36878879830330 TABLET, FILM COATED in 1 BOTTLE (68788-7983-3) 2021-08-050000-00-00NoNoCurrent
68788-7983-56878879830550 TABLET, FILM COATED in 1 BOTTLE (68788-7983-5) 2021-08-050000-00-00NoNoCurrent