FDA.reportPublic FDA data

NDC 57664-428 - 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
57664-428
Package NDCs from labels
57664-428-88, 57664-428-13, 57664-428-18
Manufacturer
CARACO PHARMACEUTICAL LABORATORIES, LTD.
Effective date
2007-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROCHLOROTHIAZIDE - CARACO PHARMACEUTICAL LABORATORIES, LTD.CARACO PHARMACEUTICAL LABORATORIES, LTD.2007-03-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-428-13HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET5001
57664-428-18HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET10001
57664-428-88HYDROCHLOROTHIAZIDE100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-428HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]13 package rows20070706_7b38ac8a-4540-4eb2-aedd-9aa966d22190.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-428-18EA - Each57664-4287b825100-5945-4632-ad42-aceeaf19186912013-02-13
57664-428-88EA - Each57664-428cb9dabf2-0621-4756-968d-cef13cf727a112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
hydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
colloidal silicon dioxideINACTIVE INGREDIENTHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
FD & C Yellow No. 6INACTIVE INGREDIENTHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
lactose monohydrateINACTIVE INGREDIENTHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
pregelatinized starchINACTIVE INGREDIENTHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1

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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC2febae4f-836e-4935-bd06-3495f87b3b822017-08-15Warnings, Adverse reactionsExact identifier
rxcui: 197770
19590BF0-BECF-5A55-C964-1642916113FA7b38ac8a-4540-4eb2-aedd-9aa966d221902007-03-27Warnings, Adverse reactionsExact identifier
spl id: 19590BF0-BECF-5A55-C964-1642916113FA
spl set id: 7b38ac8a-4540-4eb2-aedd-9aa966d22190

Reported adverse events (FAERS/openFDA)#

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