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 52 of 62 · 1,239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABY MUCUS PLUS COLD RELIEFBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.d934cc8a-1e43-4942-858a-05b5d068679a2023-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.8b1414d5-57d8-46d5-b4be-3011429bdd0d2023-08-21WarningsExact identifier
unii: ETJ7Z6XBU4
PituistatARALIA QUINQUEFOLIA, GINKGO BILOBA, ARSENICUM IODATUM, AVENA SATIVA, BARYTA CARBONICA, PHOSPHORUS, SILICEA, THYROIDINUM (SUIS), ALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUMEnergique, Inc.27a5fccb-8707-4bb5-a848-d1921bba2f7f2023-08-21WarningsExact identifier
unii: ETJ7Z6XBU4
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CellergyCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.Ratis, LLC2aebc11e-eeb7-436b-b90c-3a2f59fb74922023-08-07WarningsExact identifier
unii: ETJ7Z6XBU4
TelmisartanTELMISARTANCadila Pharmaceuticals Limited353fcb30-2fa7-4ff1-8a18-26f3ec279d002023-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP8d992a4c-8740-4636-928f-bb808eae33362023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TelmisartanTELMISARTANAmneal Pharmaceuticals of New York LLCbf2dca37-ce9c-40e4-8ad6-b8186aa7fed12023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
MEB Puri-MegaMEB PURI-MEGAKadesh Incoporation Co,Ltd018125f2-ad4b-b38a-e063-6294a90a7f6e2023-07-27WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.c100d87b-4d67-42ef-b7e2-fd3642a104b82023-07-18WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICEARatis, LLC8c2b59e1-9936-486c-9a91-153e46f377e62023-07-13WarningsExact identifier
unii: ETJ7Z6XBU4
Benicar HCTOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.881a1c32-c209-4038-9c5e-c5e46c6e05462023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TribenzorOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.2f56d0bc-236b-41a0-9fc0-21cdfea8d8902023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoironce6a0710-7c28-11e6-86bf-424c583030312023-07-11Exact identifier
unii: ETJ7Z6XBU4
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsb56a3559-6eb2-4a8d-a9a4-232d2ff0febe2023-06-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.4f82e261-6101-48ab-b161-ded5aa41cd852023-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSBryant Ranch Prepackb7d6f322-6415-4952-a2d4-7f46aca8af9d2023-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CalciforceARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICABioActive Nutritional, Inc.1609ce3e-82c2-4597-86e6-847c944ddbe62023-06-07WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICEA 6XTrue Botanica, LLCfd296871-c491-7d30-e053-6294a90ab64d2023-06-02WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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