FDA.reportPublic FDA data

Application 206568

Type
ANDA
Sponsor
HUMANWELL PURACAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENCAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALTNoNo

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
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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21a50c72e98297…

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 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
ndc (product): 30142-745
Ibuprofen minisIBUPROFENWalgreens6d1d131d-0741-4a75-8383-9322f4f3faab2026-08-06WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
ndc (product): 0363-0743
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
ndc (product): 21130-745
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
ndc (product): 21130-843
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
ndc (product): 0536-1147
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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 214 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0743Ibuprofen minisIbuprofenWalgreensANDACurrent
0363-0743Ibuprofen minisIbuprofenWalgreensANDACurrent
0363-0743Ibuprofen minisIbuprofenWalgreensANDACurrent
0363-0743Ibuprofen minisIbuprofenWalgreensANDACurrent
0363-0743Ibuprofen minisIbuprofenWalgreensANDACurrent
0363-0749IbuprofenIbuprofenWalgreensANDACurrent
0363-0749IbuprofenIbuprofenWalgreensANDACurrent
0363-0749IbuprofenIbuprofenWalgreensANDACurrent
0363-0945IbuprofenIbuprofenWalgreensANDACurrent
0363-0945IbuprofenIbuprofenWalgreensANDACurrent
0363-0945IbuprofenIbuprofenWalgreensANDACurrent
0536-1147IbuprofenIbuprofenRugby Laboratories, Inc.ANDACurrent
0536-1147IbuprofenIbuprofenRugby Laboratories, Inc.ANDACurrent
0536-1147IbuprofenIbuprofenRugby Laboratories, Inc.ANDACurrent
0536-1147IbuprofenIbuprofenRugby Laboratories, Inc.ANDACurrent
11673-745IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-745IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-745IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-745IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-745IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-745IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-745IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-749IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-749IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-749IbuprofenIbuprofenTARGET CorporationANDACurrent
21130-745IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-745IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-745IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-745IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-745IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-843Ibuprofen minisIbuprofenSafeway, Inc.ANDACurrent
21130-843Ibuprofen minisIbuprofenSafeway, Inc.ANDACurrent
21130-843Ibuprofen minisIbuprofenSafeway, Inc.ANDACurrent
21130-843Ibuprofen minisIbuprofenSafeway, Inc.ANDACurrent
21130-843Ibuprofen minisIbuprofenSafeway, Inc.ANDACurrent
30142-743Ibuprofen minisIbuprofenThe Kroger Co.ANDACurrent
30142-743Ibuprofen minisIbuprofenThe Kroger Co.ANDACurrent
30142-743Ibuprofen minisIbuprofenThe Kroger Co.ANDACurrent
30142-745IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-745IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-745IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-745IbuprofenIbuprofenThe Kroger Co.ANDACurrent
33992-0745IbuprofenIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0745IbuprofenIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0745IbuprofenIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0843Ibuprofen MinisIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0843Ibuprofen MinisIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0843Ibuprofen MinisIbuprofenASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
36800-348IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-348IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-348IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-348IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-440IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-745IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-745IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-745IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-745IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-745IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-745IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-749IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-749IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-749IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
36800-749IbuprofenIbuprofenTOP CARE (Topco Associates LLC)ANDACurrent
37012-745IbuprofenIbuprofenShopko Stores Operating Co., LLC.ANDACurrent
37012-745IbuprofenIbuprofenShopko Stores Operating Co., LLC.ANDACurrent
37012-745IbuprofenIbuprofenShopko Stores Operating Co., LLC.ANDACurrent
37012-745IbuprofenIbuprofenShopko Stores Operating Co., LLC.ANDACurrent
41520-745IbuprofenIbuprofenCare One (American Sales Company)ANDACurrent
41520-745IbuprofenIbuprofenCare One (American Sales Company)ANDACurrent
41520-745IbuprofenIbuprofenCare One (American Sales Company)ANDACurrent
41520-943Ibuprofen minisIbuprofenCare One (American Sales Company)ANDACurrent
41520-943Ibuprofen minisIbuprofenCare One (American Sales Company)ANDACurrent
41520-943Ibuprofen minisIbuprofenCare One (American Sales Company)ANDACurrent
46122-530IbuprofenIbuprofenAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
46122-530IbuprofenIbuprofenAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
46122-530IbuprofenIbuprofenAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
49035-265Ibuprofen minisIbuprofenEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-265Ibuprofen minisIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-265Ibuprofen minisIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-265Ibuprofen minisIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent