FDA.reportPublic FDA data

NDC 42571-227-32 - 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
42571-227
Requested NDC
42571-227-32
Package NDCs from labels
42571-227-30, 42571-227-90, 42571-227-05, 42571-227-10, 42571-227-32, 42571-227-11, 42571-227-41
Manufacturer
Micro Labs Limited
Effective date
2023-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TELMISARTAN - Micro Labs LimitedMicro Labs Limited2023-01-19HUMAN PRESCRIPTION DRUG LABEL
TELMISARTAN - Bryant Ranch PrepackBryant Ranch Prepack2022-02-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-227-05TELMISARTAN500 in 1 BOTTLETABLET50014
42571-227-10TELMISARTAN1000 in 1 BOTTLETABLET100014
42571-227-11TELMISARTAN10 in 1 CARTONTABLET1014
42571-227-30TELMISARTAN30 in 1 BOTTLETABLET3014
42571-227-32TELMISARTAN10 in 1 BLISTER PACKTABLET1014
42571-227-41TELMISARTAN3 in 1 CARTONTABLET314
42571-227-90TELMISARTAN90 in 1 BOTTLETABLET9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-227TELMISARTAN (TELMISARTAN) TABLET [MICRO LABS LIMITED]14Legacy NDC, 7 package rows20230121_d7c9bd41-9558-46e1-ab03-82cdf85db3fe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-227-30EA - Each42571-227fbb64ae4-d011-4ca0-a948-f504146fcb3212020-05-08

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 4 · 64 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TELMISARTANTELMISARTANChartwell RX, LLC.beaaf383-730f-4411-b5e7-15c32b53a3382025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANNorthStar RxLLC9c22a318-d1f2-4788-9331-66fed71ebf382025-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
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
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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
rxcui: 205305
unii: U5SYW473RQ
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
TelmisartanTELMISARTANJubilant Cadista Pharmacuticals Inc.e1a907a7-fad9-a860-8639-4c6136c857342025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
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

Reported adverse events (FAERS/openFDA)#

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