NDC 63629-5682-01 - 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
63629-5682
Requested NDC
63629-5682-01
Package NDCs from labels
63629-5682-1, 63629-5682-2, 63629-5682-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-04-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
telmisartan - Bryant Ranch PrepackBryant Ranch Prepack2025-04-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5682-1telmisartan30 in 1 BOTTLETABLET30104
63629-5682-2telmisartan90 in 1 BOTTLETABLET90104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5682TELMISARTAN TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20250424_44e810d4-cf04-41d3-bdf8-0681210a669f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5682-1EA - Each63629-5682c2194b09-f5ee-4ce1-9c18-8611a469f94f12025-01-14
63629-5682-2EA - Each63629-5682fd2d1d06-f596-421e-a016-7a0a9844637f12025-01-14

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 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
telmisartanTELMISARTANProficient Rx LP593a53a4-91bc-4e4a-aeff-08fc2efe3dd42020-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205150
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.