FDA.reportPublic FDA data

NDC 57664-428-88 - 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
Requested NDC
57664-428-88
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

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 1 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.f20fd735-30c7-4f89-8ceb-b6186646eea62026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 310798
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.31a3d1cb-0f52-4818-965d-7584374bb23e2026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm Drug57436cfa-9b94-89bf-e063-6394a90aa2642026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 310798
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.a85f69f5-ba97-478d-e053-2a95a90a0a972026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 310798
rxcui: 197770
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnit Dose Solutions, Inc.54f027ea-0a6e-7920-e063-6394a90ab6ae2026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 310798
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLC8c868894-667e-4a51-906a-838d63e420ba2026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 310798
rxcui: 197770
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepacka013211e-b8f8-426d-8e55-e86193f0634e2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 197770
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackf22a10a2-8f84-4060-9143-427237c512802026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.27a7e751-8aca-440e-95e4-cfecae1a24652026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 197770
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5ab641d8-cd22-4368-8070-18487dd801eb2026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 197770
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.99f45e08-897d-44dd-b48d-aa6d78981f0c2026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.2fd8f595-7aec-4308-bb17-a6f2e71900442026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDEAccord Healthcare Inc.babb1b20-fe82-40ba-8e7a-0c56fe433b4a2026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310798
rxcui: 197770
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.c2db7e27-952f-c3f6-e053-2995a90af7c12026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.c2d993ff-b11b-7a62-e053-2995a90a0b002026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 197770
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packaging2ec371a5-18ba-4ce2-9725-7f99bb73454a2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDELegacy Pharmaceutical Packaging, LLC1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd2026-03-05WarningsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e2026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 310798
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions088cb67f-3eaa-4e78-9fbe-ad2d6b7c57072026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 310798

Reported adverse events (FAERS/openFDA)#

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