FDA.reportPublic FDA data

NDC 65862-976-10 - Telmisartan 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
65862-976
Requested NDC
65862-976-10
Package NDCs from labels
65862-976-10, 65862-976-03
Manufacturer
Aurobindo Pharma Limited
Effective date
2024-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Telmisartan and Hydrochlorothiazide - Aurobindo Pharma LimitedAurobindo Pharma Limited2024-06-20Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-976-03Telmisartan and Hydrochlorothiazide3 in 1 CARTONTABLET311
65862-976-10Telmisartan and Hydrochlorothiazide10 in 1 BLISTER PACKTABLET1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-976TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 2 package rows20240621_681dfb5c-fc5c-427e-81f6-4b4e934978a2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-976-03EA - Each65862-976e287e498-dd89-46d5-8a6a-baf00098711812017-12-14
65862-976-10EA - Each65862-976648d2f6c-ac3a-44f8-a2da-e585335e2e1812017-12-14

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 28 of 62 · 1,239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD3fb16579-7cf1-873a-e063-6294a90a9ac12025-09-26WarningsExact identifier
unii: ETJ7Z6XBU4
olmesartan medoxomil-hydrochlorothiazideOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDENovadoz Pharmaceuticals LLCc8197eea-e990-4c0e-bc2d-f080bac8de172025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.dcb39c6b-430d-4b3d-ba6f-5bf1efe116aa2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMarlex Pharmaceuticals, Inc.df881501-42ae-624a-e053-2995a90ab2a02025-09-23Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limitedbbf7e20d-dfc2-4115-8788-c0cac15a11482025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Vax-SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI, MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICANutritional Specialties, Inc.cd570e98-c73f-4b38-b5b9-9f16f745ca192025-09-22WarningsExact identifier
unii: ETJ7Z6XBU4
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c334fbd-0c1e-eac0-e053-2995a90a92832025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c348fa7-1d68-4975-e053-2995a90a0ca62025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
TelmisartanTELMISARTANNuCare Pharmaceuticals, Inc.3f021f06-99df-48d1-e063-6394a90a8d0f2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Owell Naturals Draw Salve, Arnica, SiliceaARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1c9dab31-de1f-911b-e063-6294a90a03912025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
Owell Naturals Draw SalveARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1536ff1e-16b8-fbbc-e063-6394a90a628e2025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5ba2c08b-5ce5-4967-bc3b-2c73df9865af2025-09-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackec6dce85-5c0b-475c-af0b-cbbc034f698f2025-09-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack60f3f17d-fd28-406d-97ca-9f01f5f1c72c2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: ETJ7Z6XBU4
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENorthStar Rx LLC25318baf-9c2f-458f-b9ea-f52dabca49af2025-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions6b7f96c3-daf4-4029-a96b-baa37add0edb2025-09-05Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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