Ibuprofen

Product NDC
70000-0360
Requested package NDC
70000-0360-2
11-digit product format
700000360
Labeler code
70000
Product ID
70000-0360_4ac32c62-c5e5-44ee-87e8-6e69b9422817
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
ANDA206568
Marketing category
ANDA
Marketing start
2018-02-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-036070000-0360-2DDiscontinued by firm2026-08-11

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
A206568-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21

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 UTC2026-02A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0360-1EA - Each70000-0360b543e684-490b-4c08-b0bb-fff695ed779012018-08-13
70000-0360-2EA - Each70000-0360307e2c7a-cac6-4330-831a-5e528a1624eb12018-11-06
70000-0360-3EA - Each70000-0360698157d4-85c8-4cbf-979b-f919e046d60b12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0360IBUPROFEN CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]9Legacy NDC20221021_e5b2fa58-704c-4745-aa9a-0bc76a369ce4.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 1 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen minisIBUPROFENWalgreens6d1d131d-0741-4a75-8383-9322f4f3faab2026-08-06WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENP & L Development, LLCd0301d0d-fc65-420f-87fd-a08da1584d542026-06-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen MinisIBUPROFENVivunt Pharma LLCc46803db-feb7-435c-ac42-cffa99d35f462026-06-04WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENCVS Pharmacy121b13c8-0b1a-4c48-9d57-3b53a9228d342026-05-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENCVS Pharmacya6fc144a-6826-4bf7-8efb-8cdb896387f12026-05-12WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENSafeway, Inc.22927a12-6837-4d57-8e60-043000f2f2082026-01-05WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46a9424c-fd7d-f88b-e063-6294a90abceb2025-12-24WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)3a02af7e-7e69-45a6-97d7-ddc7d92b28b32025-10-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen MinisIBUPROFENFamily Dollar (FAMILY WELLNESS)72f933d8-cf01-4bb6-a552-e3cdb297038b2025-10-21WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENCVS Pharmacye241ca5f-04bd-4bc9-bd0c-ca22841c4a3c2025-07-01WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENChain Drug Consortium, LLCf0f01b97-e52c-4077-a4c6-c59736f4c1712025-06-30WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENP & L Development, LLC18b79fc5-57c8-46f1-81f3-2f9e189cdbcb2025-05-16WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENAAFES/Your Military Exchanges773b0230-a3a3-44e0-a22b-d143796ca3652025-05-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENWR Group, Inc.e9dad35a-6789-42d6-97da-521db7b164962025-03-24WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENCare One (Retail Business Services, LLC.)a6ce7484-7a32-4985-80bc-883c31be35252025-03-12WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENRugby Laboratories, Inc.05c4e6c7-bf95-4e05-b7da-7a8778de342b2024-10-28WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENP & L Development, LLC1f9c94a6-938a-420f-b90c-36b3791e97ad2024-10-07WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENSam's West, Inc74ad11b9-8976-463d-89a3-2b9f5acd0c802024-04-01WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992023-12-20WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0360-2700000360021 BOTTLE, PLASTIC in 1 BOX (70000-0360-2) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-02-280000-00-00NoNoCurrent