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 3 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 1K09F3G675
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Levico PrunusLEVICO PRUNUSUriel Pharmacy Inc.63db9374-8ee2-48cf-8799-454c958698082026-02-27WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
TelmisartanTELMISARTANGlenmark Pharmaceuticals Inc., USAc6eb489d-2946-4c14-839f-d4af761ead312026-01-28Boxed 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.