FDA.reportPublic FDA data

Telmisartan

Product NDC
71335-1723
11-digit product format
713351723
Labeler code
71335
Product ID
71335-1723_2896ac53-432d-437e-88f3-03d92b0dca36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090032
Marketing category
ANDA
Marketing start
2014-07-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Telmisartan
Listing expiration
2027-12-31

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
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1723-1Telmisartan90 in 1 BOTTLETABLET90104
71335-1723-2Telmisartan30 in 1 BOTTLETABLET30104
71335-1723-3Telmisartan180 in 1 BOTTLETABLET180104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1723TELMISARTAN TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 3 package rows20240410_c55e4fe1-f04d-4995-a706-9f432fde57e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSNc55e4fe1-f04d-4995-a706-9f432fde57e4104
205305telmisartan 80 MG Oral TabletSCDc55e4fe1-f04d-4995-a706-9f432fde57e4104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1723-17133517230190 TABLET in 1 BOTTLE (71335-1723-1) 90 tablet2024-04-040000-00-00NoNoCurrent
71335-1723-27133517230230 TABLET in 1 BOTTLE (71335-1723-2) 30 tablet2020-10-200000-00-00NoNoCurrent
71335-1723-371335172303180 TABLET in 1 BOTTLE (71335-1723-3) 180 tablet2020-10-20NoNoCurrent