Ibuprofen

Product NDC
59726-199
11-digit product format
597260199
Labeler code
59726
Product ID
59726-199_a534f0f4-1f99-4d45-a14c-beabafd5fce2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA078682
Marketing category
ANDA
Marketing start
2021-01-29
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct59726-199DDiscontinued by firm2026-10-15
excluded packagepackage59726-19959726-199-10DDiscontinued by firm2026-10-15
excluded packagepackage59726-19959726-199-16DDiscontinued by firm2026-10-15
excluded packagepackage59726-19959726-199-20DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078682-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24c2088c7a36db…
2026-09-14 22:38:342026-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2484e616aacf4f…
2026-08-18 06:07:402026-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59726-199-102023-04-19Drug Facts
59726-199-162023-04-19Drug Facts
59726-199-202023-04-19Drug Facts
59726-199-102023-01-30Drug Facts
59726-199-162023-01-30Drug Facts
59726-199-202023-01-30Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-199IBUPROFEN CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]3Legacy NDC20230420_8b27f064-3ded-453d-b656-78daf35e87bd.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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYfed2f7ae-2825-f967-e053-6294a90adc0a2023-10-05WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCardinal Health (Leader) 70000e751cb66-5fa5-4171-b061-da34aa10de6c2023-03-10WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENRite Aid Corporationa35f04f8-8c7f-5e23-e053-2995a90a30ff2023-02-08WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENWALGREEN COMPANY4ce20d2b-2dfb-4405-b545-dd1f67b2c5882022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Migraine ReliefIBUPROFENWALGREENS3d560acb-3334-4a39-9ab1-f131060e3b332022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYb9ff2469-22c7-fc70-e053-2a95a90abc492022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYbcd15c0f-8231-296f-e053-2995a90a280c2022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENWal-Mart Stores, Inc.9e5332ab-92bc-3a33-e053-2995a90a642d2022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Dye-Free IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.d0eff659-6445-a56a-e053-2995a90a72e92022-12-27WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.553d16e1-928e-4919-bc53-6683a035e2b02022-12-27WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENKROGER COMPANY3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d2022-12-27WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.aa91952b-512f-0ead-e053-2995a90a94552022-12-21WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENBionpharma Inc.ba89fbe6-546a-e10c-e053-2a95a90ade0c2022-12-20WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7f510feb-023c-4974-af6d-3e7a30cef3622022-11-07WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Migraine ReliefIBUPROFENBionpharma Inc.662ae0e0-bd44-4db4-8083-fc2e11d49abe2021-08-24WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENBionpharma Inc.d7d00fe3-c537-486e-8156-9b56b550bff52019-09-06WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENWal-Mart Stores, Incc100129d-3754-4d0e-b754-76440d55944a2019-08-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Ibuprofen 200IBUPROFENWALGREEN COMPANY5fe0bdfa-1d5b-4657-a32b-f531b69bac0d2019-08-13WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCb234d42e-1333-48a1-8565-35d9759e80852019-03-29WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-199-10597260199101 BOTTLE, PLASTIC in 1 BOX (59726-199-10) > 10 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-01-290000-00-00NoNoCurrent
59726-199-1659726019916160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (59726-199-16) 2021-01-290000-00-00NoNoCurrent
59726-199-20597260199201 BOTTLE, PLASTIC in 1 BOX (59726-199-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-01-290000-00-00NoNoCurrent