FDA.reportPublic FDA data

NDC 57451-5024-3 - 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
57451-5024
Requested NDC
57451-5024-3
Package NDCs from labels
57451-5024-1, 57451-5024-2, 57451-5024-3
Manufacturer
Ipca Laboratories Limited
Effective date
2009-04-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrochlorothiazide - Ipca Laboratories LimitedIpca Laboratories Limited2009-04-15HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57451-5024-1Hydrochlorothiazide30 in 1 BOTTLECAPSULE301
57451-5024-2Hydrochlorothiazide100 in 1 BOTTLECAPSULE1001
57451-5024-3Hydrochlorothiazide1000 in 1 BOTTLECAPSULE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57451-5024HYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]13 package rows20090623_0bbc6889-0fd5-4763-97f4-061f5a50c7b1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
black iron oxideINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
corn starchINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
D&C Red no. 28INACTIVE INGREDIENTHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
D&C Yellow no. 10INACTIVE INGREDIENTHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
FD&C Blue no.1INACTIVE INGREDIENTHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
gelatinINACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
sodium starch glycolateINACTIVE INGREDIENTHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [IPCA LABORATORIES LIMITED]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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions39d4dbd3-8f24-4898-a240-e94e06fa229a2024-04-11Warnings, Adverse reactionsExact identifier
rxcui: 199903
hydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.cb7712f3-9a0b-442d-859d-8be5e6e2529a2024-03-29Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsbd5728a2-6322-42e3-bd1e-e4915750e3982023-12-28Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labsd6b933c6-f5f8-406a-84d6-b22c6040482a2023-10-19Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP460f922c-1fda-44a5-889e-d7009883176b2023-05-01Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC69c41abb-75f4-429b-905a-1ce967924aee2023-04-04Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPc1052d38-fd75-40c2-a685-0e889009be0b2023-02-01Warnings, Adverse reactionsExact identifier
rxcui: 199903
hydrochlorothiazideHYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited34703033-14c4-459c-8b8f-2f2e1145aff72023-01-30Warnings, Adverse reactionsExact identifier
rxcui: 199903
hydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP98edae8a-99dc-4f26-a956-3ad58bf38a262022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPb54ec2b1-3325-46a1-b654-8a75dc41ab0a2022-03-01Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCf0b993f2-9771-42e3-b10e-09719189e2bd2021-01-19Warnings, Adverse reactionsExact identifier
rxcui: 199903
hydrochlorothiazideHYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.841b7962-bf5d-4c45-b594-80b17ba5187d2020-09-11Warnings, Adverse reactionsExact identifier
rxcui: 199903
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC0f7a608d-748b-49a9-a4b3-b3fdcab53ce02017-12-21Warnings, Adverse reactionsExact identifier
rxcui: 199903
9F30C42C-50EA-A563-9DBB-1240C9D822F40bbc6889-0fd5-4763-97f4-061f5a50c7b12009-04-15Warnings, Adverse reactionsExact identifier
spl id: 9F30C42C-50EA-A563-9DBB-1240C9D822F4
spl set id: 0bbc6889-0fd5-4763-97f4-061f5a50c7b1

Reported adverse events (FAERS/openFDA)#

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