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 33 of 62 · 1,239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candesartan Cilexetil and HydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited76630807-9717-44be-946d-756038cf677e2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Vax SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITISNutritional Specialties, Inc.6f8cfcad-4d23-44d3-9369-22b575b1e7e62025-05-15WarningsExact identifier
unii: ETJ7Z6XBU4
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions02a481cb-ad80-41bb-82d3-c237b00ed8d72025-05-15Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: ETJ7Z6XBU4
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1570f1ad-8372-477f-89c3-8c9ce01e27d12025-05-07Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 1K09F3G675
telmisartanTELMISARTANPD-Rx Pharmaceuticals, Inc.56a72ddf-c2a2-45ce-91b1-1fcfbff52c102025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANBryant Ranch Prepack32489e86-0432-4d74-92f6-15e7450f52fa2025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b02025-04-29Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.fea5a353-9b13-9b87-e053-6394a90a627d2025-04-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDOCSMEDI Co., Ltd.3382776a-a10e-1823-e063-6394a90a6f912025-04-24WarningsExact identifier
unii: ETJ7Z6XBU4
telmisartanTELMISARTANBryant Ranch Prepack44e810d4-cf04-41d3-bdf8-0681210a669f2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENorthStar RxLLC364af4fe-cde8-466f-b56f-d93d532b56f52025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEStrides Pharma Science Limited9b76e441-e6a5-4036-8276-b7788ade5c442025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bestmade Natural Products BM133 PelletsSILICEA, CARBO VEG, AURUM MUR, THUJA OCC, ACID NIT, FERRUM IODBestmade Natural Products3242a579-23f3-0063-e063-6394a90a93342025-04-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Silicea 8xSILICEABestmade Natural Products31e15fbf-2439-8d96-e063-6294a90a46ed2025-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
ZestoreticLISINOPRIL AND HYDROCHLOROTHIAZIDEAlmatica Pharma Inc.0d3a966f-f937-05a8-a90f-5aa52ebbd6132025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
telmisartanTELMISARTANAscend Laboratories, LLC29bddc43-2809-4e1f-ae35-2865e15e9bb62025-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Silicea 6x Lactose-freeSILICEA ORGANIC CANE SUGARBestmade Natural Products2991ecbf-925e-00f3-e063-6294a90a37bf2025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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