FDA.reportPublic FDA data

NDC 65841-804-30 - 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
65841-804
Requested NDC
65841-804-30
Package NDCs from labels
65841-804-06, 65841-804-16, 65841-804-01, 65841-804-05, 65841-804-10, 65841-804-30, 65841-804-78
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
telmisartan - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-804-01telmisartan100 in 1 BOTTLETABLET1008
65841-804-05telmisartan500 in 1 BOTTLETABLET5008
65841-804-06telmisartan30 in 1 BOTTLETABLET308
65841-804-10telmisartan1000 in 1 BOTTLETABLET10008
65841-804-16telmisartan90 in 1 BOTTLETABLET908
65841-804-30telmisartan1 in 1 BLISTER PACKTABLET18
65841-804-78telmisartan30 in 1 CARTONTABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-804TELMISARTAN TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20240815_2e3cc412-fa44-4304-aabc-d6e412f81fbf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
SORBITOLINACTIVE INGREDIENT506T60A25RTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1

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 7 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ferrum rosatum GraphitesFERRUM ROSATUM GRAPHITESUriel Pharmacy Inc.1a4ca338-eada-4c0f-8bce-480244940c892025-06-27WarningsExact identifier
unii: 1K09F3G675
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 506T60A25R
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 1K09F3G675
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
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
TelmisartanTELMISARTANJubilant Cadista Pharmacuticals Inc.e1a907a7-fad9-a860-8639-4c6136c857342025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 506T60A25R
Micardis HCTTELMISARTAN AND HYDROCHLOROTHIAZIDEBoehringer Ingelheim Pharmaceuticals, Inc.b078dae2-664d-4144-847a-3b9d9b5574022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepacke2deff49-b75e-4aaa-8114-d5ea1e3a94a52024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282755
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackb4ae8694-2af4-4acb-8634-b40c1cb6fb412024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
unii: U5SYW473RQ
TelmisartanTELMISARTANBryant Ranch Prepackf13e0919-5ee2-4855-b7c8-c8ab423769dd2024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205305
unii: U5SYW473RQ
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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