telmisartan and hydrochlorothiazide

Product NDC
0054-0547
11-digit product format
000540547
Labeler code
0054
Product ID
0054-0547_426556da-fe30-4161-9845-e1a7dfbeafda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA021162
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-02-28
Marketing end
2022-11-30
Substance
TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength
80 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0547-18EA - Each0054-0547d9c8983d-4b75-42cf-b0e4-65dd39e127bb12014-04-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0547-18000540547183 BLISTER PACK in 1 CARTON (0054-0547-18) > 10 TABLET in 1 BLISTER PACK3 blister pack2014-02-280000-00-00NoNoCurrent