Telmisartan

Product NDC
68071-5178
11-digit product format
680715178
Labeler code
68071
Product ID
68071-5178_1b5699a7-4338-10b7-e063-6294a90a604a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
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
68071-5178-36807151780330 TABLET in 1 BOX (68071-5178-3) 30 tablet2020-03-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TelmisartanNuCare Pharmaceuticals,Inc.2024-06-20HUMAN PRESCRIPTION DRUG LABEL3