FDA.reportPublic FDA data

telmisartan 80 MG / amLODIPine 10 MG Oral Tablet

RxCUI
876519
RxNorm name
telmisartan 80 MG / amLODIPine 10 MG Oral Tablet
Display name
telmisartan 80 MG / amLODIPine 10 MG Oral Tablet
Full name
telmisartan 80 MG / amLODIPine 10 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINELupin Pharmaceuticals, Inc.a97fefa6-99e6-4eb7-9393-ab2252a2c7d82023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 876519
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEAlembic Pharmaceuticals Limited15b438b4-4874-43f4-a50a-4e6f3e5530ac2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 876519
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEMylan Pharmaceuticals Inc.ca60a4d5-ace7-4889-94ee-e2265fd638112018-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 876519

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a97fefa6-99e6-4eb7-9393-ab2252a2c7d8telmisartan 80 MG / amLODIPine 10 MG Oral Tablet [PSN] · amlodipine 10 MG / telmisartan 80 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral Tablet [SY]310These highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 200920231215
ca60a4d5-ace7-4889-94ee-e2265fd63811telmisartan 80 MG / amLODIPine 10 MG Oral Tablet [PSN] · amlodipine 10 MG / telmisartan 80 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral Tablet [SY]39These highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 200920181114
15b438b4-4874-43f4-a50a-4e6f3e5530actelmisartan 80 MG / amLODIPine 10 MG Oral Tablet [PSN] · amlodipine 10 MG / telmisartan 80 MG Oral Tablet [SCD] · amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral Tablet [SY]34These highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 200920230130