Triamterene and Hydrochlorothiazide

Product NDC
67544-408
11-digit product format
675440408
Labeler code
67544
Product ID
67544-408_ff9ed6f2-d9f0-4bbb-b5f9-cb8498ff2928
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA019129
Marketing category
NDA
Marketing start
2011-02-09
Marketing end
0000-00-00
Substance
TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength
38 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-408-30EA - Each67544-4085fa1b82e-0066-48c5-abeb-194f5abc1b1d12013-06-04
67544-408-45EA - Each67544-40882753e5f-4c04-43a4-8f2b-7679973de52812014-09-03
67544-408-60EA - Each67544-4089037f12d-ebfa-40c4-bce4-9ac2cfee3dcf12013-06-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-408-306754404083030 TABLET in 1 BOTTLE, PLASTIC (67544-408-30) 30 tablet2011-02-090000-00-00NoNoCurrent
67544-408-316754404083131 TABLET in 1 BOTTLE, PLASTIC (67544-408-31) 31 tablet2011-02-090000-00-00NoNoCurrent
67544-408-456754404084545 TABLET in 1 BOTTLE, PLASTIC (67544-408-45) 45 tablet2011-02-090000-00-00NoNoCurrent
67544-408-606754404086090 TABLET in 1 BOTTLE, PLASTIC (67544-408-60) 90 tablet2014-04-050000-00-00NoNoCurrent