FDA.reportPublic FDA data

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 4 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
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
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
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
application number: ANDA205150
rxcui: 282755
unii: U5SYW473RQ
telmisartanTELMISARTANBryant Ranch Prepack32489e86-0432-4d74-92f6-15e7450f52fa2025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205150
rxcui: 205305
unii: U5SYW473RQ
telmisartanTELMISARTANBryant Ranch Prepack44e810d4-cf04-41d3-bdf8-0681210a669f2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205150
ndc (package): 63629-5682-1
ndc (package): 63629-5682-2
ndc (product): 63629-5682
ndc11 (package): 63629568201
rxcui: 205304
spl id: 33603cf2-4536-8522-e063-6394a90a379f
spl set id: 44e810d4-cf04-41d3-bdf8-0681210a669f
unii: U5SYW473RQ
telmisartanTELMISARTANAscend Laboratories, LLC29bddc43-2809-4e1f-ae35-2865e15e9bb62025-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205150
ndc (product): 67877-483
rxcui: 205304
rxcui: 282755
rxcui: 205305
spl id: 3176efce-402d-3398-e063-6294a90a2f27
spl set id: 29bddc43-2809-4e1f-ae35-2865e15e9bb6
unii: U5SYW473RQ
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
TelmisartanTELMISARTANJubilant Cadista Pharmacuticals Inc.e1a907a7-fad9-a860-8639-4c6136c857342025-01-15Boxed 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.