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

openFDA Listing Details

Product ID
71335-1723_2896ac53-432d-437e-88f3-03d92b0dca36
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Telmisartan
Generic name
Telmisartan
Dosage form
TABLET
Route
ORAL
Marketing start
2014-07-07
Marketing category
ANDA
Application number
ANDA090032
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]
Listing expiration
2027-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiU5SYW473RQ
Rxcui205305
Spl Set Idc55e4fe1-f04d-4995-a706-9f432fde57e4
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U5SYW473RQTELMISARTAN144701-48-4TELMISARTAN

Packages

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TelmisartanBryant Ranch Prepack2026-05-20HUMAN PRESCRIPTION DRUG LABEL104