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 2 of 18 · 344 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TelmisartanTELMISARTANRedpharm Drug5743c58e-deab-ac93-e063-6294a90ac1eb2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.1080fcea-a5da-499d-a855-690c135590712026-07-17Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATENuCare Pharmaceuticals, Inc.4926f00c-ee19-3e10-e054-00144ff88e882026-07-17Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.4ad016ec-e158-4325-9f45-4460cf78dd982026-07-16Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
WIDAPLIKTELMISARTAN, AMLODIPINE AND INDAPAMIDEAzurity Pharmaceuticals, Inc.a30ff81d-420b-40ea-83d8-670260a93fff2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.d09173a1-5e3c-4c86-8c7c-15238925ef502026-07-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
CaduetAMLODIPINE AND ATORVASTATINPfizer Laboratories Div Pfizer Inc6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b62026-06-25Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb552026-06-24Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
Amlodipine BesylateAMLODIPINE BESYLATEUnit Dose Solutions, Inc.5467eee5-1519-7859-e063-6294a90afed12026-06-16Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATESafecor Health LLC572bc798-c3d9-4fe2-98be-8e1913bda8f32026-06-12Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEChina Resources Saike Pharmaceutical Co., Ltd.3518853a-4c5b-4161-a178-8da7f656f0092026-06-08Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
telmisartanTELMISARTANREMEDYREPACK INC.09d31eee-cd22-4918-a889-3eb4d29695252026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP61cb7f91-d1f6-40bd-98a3-c461098a20d92026-06-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
TelmisartanTELMISARTANAlembic Pharmaceuticals Limited4be6575f-ea8d-4cd8-a49d-3d1c93f2621a2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANAlembic Pharmaceuticals Inc.c62d424c-7630-413c-be2c-3932831c3f1d2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepackf546047f-1cc6-4bbe-a67b-b5c9815b89af2026-05-22Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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