FDA.reportPublic FDA data

NDC 46708-185-03 - Telmisartan and Amlodipine

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
46708-185
Requested NDC
46708-185-03
Package NDCs from labels
46708-185-03, 46708-185-10, 46708-185-30
Manufacturer
Alembic Pharmaceuticals Limited
Effective date
2026-10-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Telmisartan and Amlodipine - Alembic Pharmaceuticals LimitedAlembic Pharmaceuticals Limited2026-10-26Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-01These 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: 2009
2023-02-01These 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: 2009
2023-01-30These 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: 2009
2023-01-30These 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: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-185-08Telmisartan and Amlodipine8 in 1 BLISTER PACKTABLET84
46708-185-08Telmisartan and Amlodipine80 in 1 CARTONTABLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-185TELMISARTAN AND AMLODIPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 2 package rows20230202_15b438b4-4874-43f4-a50a-4e6f3e5530ac.zip

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 18 · 344 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.27b0c628-820a-48bf-a411-86c0ebd4cc8d2026-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.0f253cac-67ac-4b03-b1a8-f2c345938dda2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.dc206611-5188-40a6-b025-61db41f68a5a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.2542895b-c8f8-4f21-9e12-f5a7fe17f9052026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC5af8493b-2b73-859c-e063-6394a90a46202026-09-08Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINApotex Corp.4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b032026-09-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEGSMS, Incorporated9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf2026-09-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs6efc0ef6-0424-44fc-a9ea-eb30c3b832392026-09-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQPharma, Inc.5866d1ee-631d-d09e-e063-6294a90abe012026-08-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
TelmisartanTELMISARTANREMEDYREPACK INC.57da6ef2-2e86-4e4d-90df-73a2a8cf97f62026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
AMLODIPINE BESYLATEAMLODIPINE BESYLATERedpharm Drug58336a97-807a-2859-e063-6294a90ad3382026-08-04Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
TelmisartanTELMISARTANREMEDYREPACK INC.91215664-6e19-4e04-9ae7-ab56647994262026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.58a67272-c4c7-4e2c-85a5-9d39034d12c32026-07-27Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEMajor Pharmaceuticalsedf9b22c-e37e-4b4e-8a64-20bb036c7d2d2026-07-27Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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