Telmisartan

Product NDC
0054-0544
11-digit product format
000540544
Labeler code
0054
Product ID
0054-0544_a80037e5-f0ac-47cf-84f3-a1c5d3a9300d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
NDA020850
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-08
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0544-18EA - Each0054-054423617c07-794e-4203-8c03-0d4203d57bdb12014-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0544-18000540544183 BLISTER PACK in 1 CARTON (0054-0544-18) > 10 TABLET in 1 BLISTER PACK3 blister pack2014-01-080000-00-00NoNoCurrent