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 54 of 62 · 1,239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect SleepADENOSINUM 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 BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: ETJ7Z6XBU4
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsef100fa1-dd63-4287-8543-480a82ace1682023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsf1ef2a2c-7b8d-4127-8f47-29e430fba70b2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions54224596-325d-473e-adb5-1c86857aba342023-02-04Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPc1052d38-fd75-40c2-a685-0e889009be0b2023-02-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP84dba61d-cae2-4f21-9a9e-3088f356f8382023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPc4fe84e3-c291-4220-95c1-a2bd02b1e1342023-02-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
hydrochlorothiazideHYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited34703033-14c4-459c-8b8f-2f2e1145aff72023-01-30Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited9492a1cd-c012-4b43-931d-235220065e1e2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEAlembic Pharmaceuticals Limited15b438b4-4874-43f4-a50a-4e6f3e5530ac2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited3b80f726-9e1e-4d44-ad4f-afd10e26292f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited5b476740-e3f0-4f68-b07c-cd9eb2fa27ca2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283317
rxcui: 283316
rxcui: 477130
unii: 0J48LPH2TH
unii: U5SYW473RQ
SiliceaSILICON DIOXIDEBoiron86d2db09-9c46-37f7-e053-2a91aa0a326f2023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b50e-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b4fb-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited8c65d555-8db8-40d9-be30-309ef09f19be2023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited538ea34a-1ac3-48c8-b841-43be09285e122023-01-17Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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