Telmisartan

Product NDC
68071-3892
11-digit product format
680713892
Labeler code
68071
Product ID
68071-3892_3f021f0f-b705-16c1-e063-6294a90aacef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA207882
Marketing category
ANDA
Marketing start
2017-08-20
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
68071-3892-168071389201100 TABLET in 1 BOTTLE (68071-3892-1) 100 tablet2025-09-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TelmisartanNuCare Pharmaceuticals, Inc.2025-09-17HUMAN PRESCRIPTION DRUG LABEL1