FDA.reportPublic FDA data

NDC 70518-2572-01 - 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
70518-2572
Requested NDC
70518-2572-01
Package NDCs from labels
70518-2572-0, 70518-2572-1, 70518-2572-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-27
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.2026-07-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-10These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
2023-03-10These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
2023-01-30These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
2023-01-30These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2572-0Telmisartan3 in 1 CARTONTABLET37
70518-2572-0Telmisartan10 in 1 BLISTER PACKTABLET107
70518-2572-1Telmisartan30 in 1 BOTTLETABLET307

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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TelmisartanTELMISARTANAmneal Pharmaceuticals LLC20a60231-64f0-4751-aa81-6c0e643341792023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANModavar Pharmaceuticals LLCa075633a-2a2a-4e88-8ede-b49a3920a16c2023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANA-S Medication Solutions509cd338-24db-41d1-a115-9dc9991707172023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205305
unii: U5SYW473RQ
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e80f232c-c1c4-4524-a0a5-d23ee0d1f3b72023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANCadila Pharmaceuticals Limited353fcb30-2fa7-4ff1-8a18-26f3ec279d002023-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANAmneal Pharmaceuticals of New York LLCbf2dca37-ce9c-40e4-8ad6-b8186aa7fed12023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
TelmisartanTELMISARTANMylan Pharmaceuticals Inc.c3658bc8-1524-43db-930e-66f9ac01b8082023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205304
rxcui: 282755
rxcui: 205305
unii: U5SYW473RQ
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEAlembic Pharmaceuticals Limited15b438b4-4874-43f4-a50a-4e6f3e5530ac2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited5b476740-e3f0-4f68-b07c-cd9eb2fa27ca2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANProficient Rx LP593a53a4-91bc-4e4a-aeff-08fc2efe3dd42020-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205305
unii: U5SYW473RQ
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEMylan Pharmaceuticals Inc.ca60a4d5-ace7-4889-94ee-e2265fd638112018-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ

Reported adverse events (FAERS/openFDA)#

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