FDA.reportPublic FDA data

NDC 50268-327-11 - Fosinopril sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50268-327
Requested NDC
50268-327-11
Package NDCs from labels
50268-327-11, 50268-327-15
Manufacturer
AvPAK
Effective date
2022-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fosinopril sodium - AvPAKAvPAK2022-01-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-327-11EA - Each50268-327fedc876b-14f9-4500-9433-c9b66101966d12020-09-14
50268-327-15EA - Each50268-32710274445-ee65-443d-8d46-5cefc27f2c0212020-09-14

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 1 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosinopril SodiumFOSINOPRIL SODIUMChartwell RX, LLCff1323cc-7ad8-488d-94a7-a11555db78a72025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857183
rxcui: 857187
rxcui: 857169
unii: NW2RTH6T2N
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Fosinopril SodiumFOSINOPRIL SODIUMAurobindo Pharma Limitedaee04f17-8ee9-42f5-861f-b6ba17220ca42024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857183
rxcui: 857187
rxcui: 857169
unii: NW2RTH6T2N
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited35019655-9a30-4305-a262-936ad0e730712024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NW2RTH6T2N
Fosinopril SodiumFOSINOPRILBryant Ranch Prepackfc38f1bb-f175-4a81-8ed9-c8701efdea352023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857169
unii: NW2RTH6T2N
Fosinopril sodiumFOSINOPIRL SODIUMBryant Ranch Prepack3d521d4d-29f8-40d7-971b-0efb68dfbff22023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205670
rxcui: 857169
unii: NW2RTH6T2N
Fosinopril SodiumFOSINOPRILBryant Ranch Prepack6562a532-b502-4515-88df-591d71293b562023-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857183
unii: NW2RTH6T2N
Fosinopril sodiumFOSINOPRIL SODIUMA-S Medication Solutions46e3e4e8-c611-4d4f-ad57-050b4c01fcd82023-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205670
rxcui: 857187
unii: NW2RTH6T2N
Fosinopril sodiumFOSINOPRIL SODIUMBryant Ranch Prepackee78de8e-22f4-4c3b-a721-e9464d704eda2023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205670
rxcui: 857187
unii: NW2RTH6T2N
Fosinopril sodiumFOSINOPRIL SODIUMExelan Pharmaceuticals, Inc.e2ff3171-a17a-456a-9272-ca1682b01d192023-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857183
rxcui: 857187
rxcui: 857169
unii: NW2RTH6T2N
Fosinopril SodiumFOSINOPRILA-S Medication Solutions880e5bf4-ced8-4765-a5c2-2361fd06ed9c2023-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857187
rxcui: 857169
unii: NW2RTH6T2N
Fosinopril SodiumFOSINOPRILCipla USA Inc.736fe52f-69fb-48b2-b1c5-f065318785382023-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857183
rxcui: 857187
rxcui: 857169
unii: NW2RTH6T2N
eeb7c7cf-3726-d892-e053-2995a90a00c6acb10557-4ce8-1f85-e053-2a95a90a18312022-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: acb10557-4ce8-1f85-e053-2a95a90a1831
Fosinopril sodiumFOSINOPIRL SODIUMSolco Healthcare LLC0a66f606-5e6f-473d-8a1e-9ef316adb2e22021-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205670
ndc (product): 43547-388
ndc (product): 43547-387
ndc (product): 43547-386
rxcui: 857183
rxcui: 857187
rxcui: 857169
spl id: e39b61db-42b8-4ddf-89d1-549c08d49e71
spl set id: 0a66f606-5e6f-473d-8a1e-9ef316adb2e2
unii: NW2RTH6T2N
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDECIPLA USA INC.4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2020-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NW2RTH6T2N

Reported adverse events (FAERS/openFDA)#

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