telmisartan

Product NDC
65841-806
11-digit product format
658410806
Labeler code
65841
Product ID
65841-806_9e0aa50a-1fac-4086-b7b6-811cec3f524b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203325
Marketing category
ANDA
Marketing start
2014-08-27
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U5SYW473RQTELMISARTAN144701-48-4TELMISARTAN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65841-806-0165841080601100 TABLET in 1 BOTTLE (65841-806-01) 100 tablet2014-08-27NoNoHistorical
65841-806-0565841080605500 TABLET in 1 BOTTLE (65841-806-05) 500 tablet2014-08-27NoNoHistorical
65841-806-066584108060630 TABLET in 1 BOTTLE (65841-806-06) 30 tablet2014-08-27NoNoHistorical
65841-806-10658410806101000 TABLET in 1 BOTTLE (65841-806-10) 1000 tablet2014-08-27NoNoHistorical
65841-806-166584108061690 TABLET in 1 BOTTLE (65841-806-16) 90 tablet2014-08-27NoNoHistorical
65841-806-786584108067830 BLISTER PACK in 1 CARTON (65841-806-78) / 1 TABLET in 1 BLISTER PACK (65841-806-30) 30 blister pack2014-08-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TELMISARTAN TABLETSZydus Lifesciences Limited2024-08-12HUMAN PRESCRIPTION DRUG LABEL8