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 58 of 62 · 1,239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILICEASILICEARxhomeo Private Limited d.b.a. Rxhomeo, Inc0000025c-6dbf-4af7-a741-5cbacaed519a2021-09-02WarningsExact identifier
unii: ETJ7Z6XBU4
HLU PNEUMO DROPSARSENICUM IODATUM, CALCAREA PHOSPHORICA, CARBO VEGETABILIS, ORYCTOLAGUS CUNICULUS LUNG, PHELLANDRIUM AQUATICUM, SILICEA, STANNUM METALLICUM, SULPHUR, THYMUS VULGARISSeroyal USA2f0acce5-aad5-1dd3-e054-00144ff88e882021-07-22WarningsExact identifier
unii: ETJ7Z6XBU4
Sleep AidADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Pro Weight Loss Inc.d0af311a-e975-4236-8c0e-0418efa7e45f2021-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEA 6XSILICEASeroyal USA156cb778-c6a8-0681-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: ETJ7Z6XBU4
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: ETJ7Z6XBU4
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.c67b3a39-ef78-5e81-e053-2a95a90a47862021-07-06WarningsExact identifier
unii: ETJ7Z6XBU4
candesartan cilexetil and hydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDESolco Healthcare LLC543b9806-ccfa-4144-a2a2-d0e35eaceeee2021-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA SINUS PLUSALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA -Guna spab48c5634-24cf-343e-e053-2995a90a3a9a2021-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA OSTEOARNICA MONTANA ROOT - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - EQUISETUM HYEMALE - FUMARIC ACID - SUS SCROFA UMBILICAL CORD - SUS SCROFA OVARY - SUS SCROFA PLACENTA - COMFREY ROOT - SUCCINIC ACID - SILICON DIOXIDE -Guna spaba4462d6-9751-530f-e053-2995a90a1f162021-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
Flora PlusALOE, ALUMINA, ANTIMON CRUD, ARG NIT, CHELIDONIUM MAJ, GAMBOGIA, GRAPHITES, HYDRASTIS, LYCOPODIUM, SILICEANET Remediesfc1ced48-bd9f-4b3f-b786-573fba0729752021-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
Scars-AdhesionsCALC FLUOR, CAUSTICUM, GRAPHITES, HYDROFLUORICUM AC, LACHESIS, PLUMB MET, RHUS TOX, SEPIA, SILICEA, THIOSINAMINUMNET Remediesb6bae38b-90c3-47bc-9d6f-8ce6640bbedc2021-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
Day and Night VitalsALLIUM SAT, ALOE, ARSENICUM ALB, BERBER VULG, CALC PHOS, CEANOTHUS, CHELIDONIUM MAJ, CHOLESTERINUM, CLEMATIS ERECTA, CONDURANGO, GAMBOGIA, HAMAMELIS, KALI BROM, KALI PHOS, LYCOPODIUM, NAT CARB, PASSIFLORA, SENNA, SILICEA, SOLIDAGO, SPIGELIA ANTH, SPONGIA, VERATRUM VIRNET Remediesd5ddba51-5f0c-4b06-8f87-3cd6faf64b792021-01-19WarningsExact identifier
unii: ETJ7Z6XBU4
MetalALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIANET Remediesf7682a4e-c767-4429-98aa-e8c5ef6560a62021-01-19WarningsExact identifier
unii: ETJ7Z6XBU4
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCf0b993f2-9771-42e3-b10e-09719189e2bd2021-01-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LPf11598d2-87ee-4292-8631-c29c54f4dfa92021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP6be05675-c4b4-4e1e-9047-044a7fc7cef62021-01-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP97b09783-7bba-4f7a-b1b3-86ccf12c7ecc2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPa6e7d8a7-f969-4a21-ac28-93c77ed1fa632021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP75b3f944-b4fc-40a5-a4e2-aec2fbab64b82021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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