telmisartan and hydrochlorthiazide

Product NDC
13668-160
11-digit product format
136680160
Labeler code
13668
Product ID
13668-160_314fbd55-3e17-4e63-9974-3b16e6b58b3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan and hydrochlorthiazide
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA201192
Marketing category
ANDA
Marketing start
2014-02-25
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; TELMISARTAN
Active strength
13 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-160-30EA - Each13668-1600c446033-ed57-4fef-897d-8a8b42b6118b12014-04-03
13668-160-72EA - Each13668-1606977aa22-9778-4eeb-9d9b-efcbaa84319012015-07-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-160-0113668016001100 TABLET in 1 BOTTLE (13668-160-01) 100 tablet2014-02-250000-00-00NoNoCurrent
13668-160-301366801603030 TABLET in 1 BOTTLE (13668-160-30) 30 tablet2014-02-250000-00-00NoNoCurrent
13668-160-721366801607230 TABLET in 1 CARTON (13668-160-72) 30 tablet2014-02-250000-00-00NoNoCurrent
13668-160-7413668016074100 TABLET in 1 CARTON (13668-160-74) 100 tablet2014-02-250000-00-00NoNoCurrent