FDA.reportPublic FDA data

NDC 62022-945-05 - FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

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
62022-945
Requested NDC
62022-945-05
Package NDCs from labels
62022-945-01, 62022-945-05, 62022-945-10
Manufacturer
Andrx Pharmaceuticals, Inc.
Effective date
2009-01-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETSAndrx Pharmaceuticals, Inc.2009-01-28HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62022-945-01FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE100 in 1 BOTTLETABLET1002
62022-945-05FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET5002
62022-945-10FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62022-945FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]23 package rows20090205_42ae28da-a613-4db4-b471-efa4e2638dc8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fosinopril SodiumACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
FosinoprilACTIVE MOIETYR43D2573WOFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
HydrochlorothiazideACTIVE MOIETY0J48LPH2THFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
FD&C Red #40 HT aluminum lakeINACTIVE INGREDIENTFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2
sodium stearyl fumarateINACTIVE INGREDIENTFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [ANDRX PHARMACEUTICALS, INC.]2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited35019655-9a30-4305-a262-936ad0e730712024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857174
rxcui: 857166
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDECIPLA USA INC.4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2020-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857174
rxcui: 857166
08FFEE24-A0C5-EA7A-853D-6613F5F9C29D42ae28da-a613-4db4-b471-efa4e2638dc82009-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 08FFEE24-A0C5-EA7A-853D-6613F5F9C29D
spl set id: 42ae28da-a613-4db4-b471-efa4e2638dc8

Reported adverse events (FAERS/openFDA)#

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