FDA.reportPublic FDA data

NDC 70518-3556-01 - Telmisartan

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
70518-3556
Requested NDC
70518-3556-01
Package NDCs from labels
70518-3556-0, 70518-3556-1, 70518-3556-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Telmisartan - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3556-0Telmisartan30 in 1 BOTTLETABLET307
70518-3556-1Telmisartan30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3556TELMISARTAN TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 2 package rows20240116_57da6ef2-2e86-4e4d-90df-73a2a8cf97f6.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 4 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
TelmisartanTELMISARTANPreferred Pharmaceuticals Inc.bf8e95fa-d181-4b46-8609-497e14a73dc12025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
unii: U5SYW473RQ
TelmisartanTELMISARTANNuCare Pharmaceuticals, Inc.3f021f06-99df-48d1-e063-6394a90a8d0f2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207882
rxcui: 205305
unii: U5SYW473RQ
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
telmisartan and hydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELifestar Pharma LLC0c1bd0f4-034e-486c-ae46-2855c8c9ebda2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TELMISARTAN AND HYDROCHLOROTHIAZIDETELMISARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare LLC47c8eee0-f0b7-4bd8-97e9-0029aa1b37db2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
telmisartanTELMISARTANPD-Rx Pharmaceuticals, Inc.56a72ddf-c2a2-45ce-91b1-1fcfbff52c102025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282755
unii: U5SYW473RQ
telmisartanTELMISARTANBryant Ranch Prepack32489e86-0432-4d74-92f6-15e7450f52fa2025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205305
unii: U5SYW473RQ
telmisartanTELMISARTANBryant Ranch Prepack44e810d4-cf04-41d3-bdf8-0681210a669f2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
unii: U5SYW473RQ
telmisartanTELMISARTANAscend Laboratories, LLC29bddc43-2809-4e1f-ae35-2865e15e9bb62025-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
TelmisartanTELMISARTANJubilant Cadista Pharmacuticals Inc.e1a907a7-fad9-a860-8639-4c6136c857342025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ

Reported adverse events (FAERS/openFDA)#

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