FDA.reportPublic FDA data

telmisartan

Product NDC
63629-5682
11-digit product format
636295682
Labeler code
63629
Product ID
63629-5682_33603cf2-4536-8522-e063-6394a90a379f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205150
Marketing category
ANDA
Marketing start
2016-06-12
Substance
TELMISARTAN
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
telmisartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELMISARTAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205304

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205304telmisartan 40 MG Oral TabletPSN44e810d4-cf04-41d3-bdf8-0681210a669f104
205304telmisartan 40 MG Oral TabletSCD44e810d4-cf04-41d3-bdf8-0681210a669f104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5682-16362956820130 TABLET in 1 BOTTLE (63629-5682-1) 30 tablet2021-01-140000-00-00NoNoCurrent
63629-5682-26362956820290 TABLET in 1 BOTTLE (63629-5682-2) 90 tablet2023-03-090000-00-00NoNoCurrent