telmisartan

Product NDC
65841-805
11-digit product format
658410805
Labeler code
65841
Product ID
65841-805_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
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U5SYW473RQTELMISARTAN144701-48-4TELMISARTAN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65841-805-0165841080501100 TABLET in 1 BOTTLE (65841-805-01) 100 tablet2014-08-27NoNoHistorical
65841-805-0565841080505500 TABLET in 1 BOTTLE (65841-805-05) 500 tablet2014-08-27NoNoHistorical
65841-805-066584108050630 TABLET in 1 BOTTLE (65841-805-06) 30 tablet2014-08-27NoNoHistorical
65841-805-10658410805101000 TABLET in 1 BOTTLE (65841-805-10) 1000 tablet2014-08-27NoNoHistorical
65841-805-166584108051690 TABLET in 1 BOTTLE (65841-805-16) 90 tablet2014-08-27NoNoHistorical
65841-805-786584108057830 BLISTER PACK in 1 CARTON (65841-805-78) / 1 TABLET in 1 BLISTER PACK (65841-805-30) 30 blister pack2014-08-27NoNoHistorical

Related DailyMed Labels

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