FDA.reportPublic FDA data

Application 091239

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

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
A091239-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-01

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGrocery Outlet, Inc.44660e1d-79c2-34ce-e063-6294a90ade3f2026-03-17WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENKroger Companybc173f1b-2e44-2c2e-e053-2a95a90a89c42025-09-24WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 41226-600
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 49483-114
ndc (product): 49483-601
ndc (product): 49483-600
IBUPROFENIBUPROFENWALGREENS7653b33c-7489-10db-e053-2991aa0ab5082025-06-06WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 0363-9601
AeroTab IbuprofenIBUPROFEN TABLETAero Healthcareddd0f7fb-ae4b-c584-e053-2a95a90a09842025-02-26WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 55305-133
VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCa6d4ceb0-2b79-496a-aa1e-27edd507ced02024-12-10WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 68210-0800
IbuprofenIBUPROFENSAM'S WEST INC16595d75-6e74-0839-e063-6394a90abc132024-05-28WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENWALGREENS746f79aa-3036-1b9b-e053-2a91aa0a1db62024-03-18WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 0363-9600
IBUPROFEN CAIBUPROFENTARGET CORPORATION8e8684fa-095e-c6d6-e053-2a95a90a15b42024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 11673-990
IBUPROFENIBUPROFENTARGET CORPORATION8e86ae68-7687-79d6-e053-2995a90ac2742024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 11673-991
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb613c44-e125-0f40-e053-2995a90a7ca52023-10-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb60e636-41fe-49fb-e053-2a95a90a06162023-09-29WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ibuprofenIBUPROFENDOLGENCORP INC8f1358aa-495a-23da-e053-2995a90aa4302023-01-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 55910-901
IBUPROFENIBUPROFENRITE AID CORPORATIONa7aa790a-6d6c-7929-e053-2995a90a1cf82022-01-04WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 11822-7891
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED3c8df1e5-61bc-4e70-b6b9-8973986ad5892021-12-21WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 25000-117
ndc (product): 25000-114
IBUPROFENIBUPROFENRITE AID CORPORATIONa7abac4c-7695-cfe8-e053-2a95a90ac1cd2021-10-30WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 11822-7892

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9600IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9600IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9600IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9600IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9600IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9601IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9601IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9601IBUPROFENIBUPROFENWALGREENSANDACurrent
0363-9601IBUPROFENIBUPROFENWALGREENSANDACurrent
11383-151IbuprofenIbuprofenWeeks & Leo Co., Inc.ANDACurrent
11673-990IBUPROFEN CAIBUPROFENTARGET CORPORATIONANDACurrent
11673-990IBUPROFEN CAIBUPROFENTARGET CORPORATIONANDACurrent
11673-991IBUPROFENIBUPROFENTARGET CORPORATIONANDACurrent
11673-991IBUPROFENIBUPROFENTARGET CORPORATIONANDACurrent
11822-7891IBUPROFENIBUPROFENRITE AID CORPORATIONANDACurrent
11822-7891IBUPROFENIBUPROFENRITE AID CORPORATIONANDACurrent
11822-7891IBUPROFENIBUPROFENRITE AID CORPORATIONANDACurrent
11822-7892IBUPROFENIBUPROFENRITE AID CORPORATIONANDACurrent
11822-7892IBUPROFENIBUPROFENRITE AID CORPORATIONANDACurrent
12634-518IbuprofenIbuprofenApotheca, IncANDACurrent
16103-396IbuprofenIbuprofenPharbest Pharmaceuticals, Inc.ANDACurrent
25000-114IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-114IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-114IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-117IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-117IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-117IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
41226-600IBUPROFENIBUPROFENKroger CompanyANDACurrent
49483-114IbuprofenIbuprofenTIME CAP LABORATORIES,INCANDACurrent
49483-114IbuprofenIbuprofenTIME CAP LABORATORIES,INCANDACurrent
49483-600IBUPROFENIBUPFROFENTIME CAP LABORATORIES,INCANDACurrent
49483-600IBUPROFENIBUPFROFENTIME CAP LABORATORIES,INCANDACurrent
49483-600IBUPROFENIBUPFROFENTIME CAP LABORATORIES,INCANDACurrent
49483-600IBUPROFENIBUPFROFENTIME CAP LABORATORIES,INCANDACurrent
49483-600IBUPROFENIBUPFROFENTIME CAP LABORATORIES,INCANDACurrent
49483-601IBUPROFENIBUPROFENTIME CAP LABORATORIES,INCANDACurrent
49483-601IBUPROFENIBUPROFENTIME CAP LABORATORIES,INCANDACurrent
49483-601IBUPROFENIBUPROFENTIME CAP LABORATORIES,INCANDACurrent
49483-601IBUPROFENIBUPROFENTIME CAP LABORATORIES,INCANDACurrent
49483-601IBUPROFENIBUPROFENTIME CAP LABORATORIES,INCANDACurrent
50090-2463IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2487IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
52605-114IbuprofenIbuprofenPolygen Pharmaceuticals LLCANDACurrent
52605-117IbuprofenIbuprofenPolygen Pharmaceuticals LLCANDACurrent
52904-447Pain ReliefIBUPROFENSelect CorporationANDACurrent
52904-486Pain Relief Anti inflammatoryIBUPROFENSelect CorporationANDACurrent
53002-5710IbuprofenIbuprofenRPK Pharmaceuticals, Inc.ANDACurrent
53002-5710IbuprofenIbuprofenRPK Pharmaceuticals, Inc.ANDACurrent
54348-836IbuprofenIbuprofenPharmpak, Inc.ANDACurrent
54348-836IbuprofenIbuprofenPharmpak, Inc.ANDACurrent
54473-308CounterActIbuprofenMelaleuca, IncANDACurrent
54473-308CounterActIbuprofenMelaleuca, IncANDACurrent
55305-133AeroTab Ibuprofenibuprofen tabletAero HealthcareANDACurrent
55910-901ibuprofenibuprofenDOLGENCORP INCANDACurrent
55910-901ibuprofenibuprofenDOLGENCORP INCANDACurrent
61715-059IbuprofenIbuprofenKinrayANDACurrent
61715-061IbuprofenIbuprofenKinrayANDACurrent
61715-167IbuprofenIbuprofenKinray, Inc.ANDACurrent
61786-948IBUPROFENIBUPROFENREMEDYREPACK INC.ANDACurrent
66424-396IbuprofenIbuprofenSDA Laboratories, Inc.ANDACurrent
67060-002IBUPROFENIBUPROFEN 200MGADVANCED FIRST AID, INC.ANDACurrent
68071-3074IbuprofenIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3074IbuprofenIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4563IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4563IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68210-0080Assured IbuprofenIbuprofenSpirit Pharmaceutical LLCANDACurrent
68210-0080Assured IbuprofenIbuprofenSpirit Pharmaceutical LLCANDACurrent
68210-0080Assured IbuprofenIbuprofenSpirit Pharmaceutical LLCANDACurrent
68210-0080Assured IbuprofenIbuprofenSpirit Pharmaceutical LLCANDACurrent
68210-0080Assured IbuprofenIbuprofenSpirit Pharmaceutical LLCANDACurrent
68210-0800VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-0800VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-0800VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-0800VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-0800VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCANDACurrent
69168-383Ibuprofen 200mg383 Ibuprofen 200mgAllegiant HealthANDACurrent
69168-383Ibuprofen 200mg383 Ibuprofen 200mgAllegiant HealthANDACurrent
71335-0223IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-0223IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
76168-012IbuprofenIbuprofenVelocity PharmaANDACurrent