FDA.reportPublic FDA data

telmisartan

Product NDC
71335-1428
11-digit product format
713351428
Labeler code
71335
Product ID
71335-1428_33efc366-1dbf-9c51-e063-6294a90a4d0d
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
80 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
TELMISARTAN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205305

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
71335-1428-1telmisartan90 in 1 BOTTLETABLET906
71335-1428-2telmisartan30 in 1 BOTTLETABLET306
71335-1428-3telmisartan180 in 1 BOTTLETABLET1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1428TELMISARTAN TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 3 package rows20250501_32489e86-0432-4d74-92f6-15e7450f52fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSN32489e86-0432-4d74-92f6-15e7450f52fa6
205305telmisartan 80 MG Oral TabletSCD32489e86-0432-4d74-92f6-15e7450f52fa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1428-17133514280190 TABLET in 1 BOTTLE (71335-1428-1) 90 tablet2021-12-280000-00-00NoNoCurrent
71335-1428-27133514280230 TABLET in 1 BOTTLE (71335-1428-2) 30 tablet2019-12-060000-00-00NoNoCurrent
71335-1428-371335142803180 TABLET in 1 BOTTLE (71335-1428-3) 180 tablet2025-04-29NoNoHistorical