Triamterene and Hydrochlorothiazide

Product NDC
63187-465
11-digit product format
631870465
Labeler code
63187
Product ID
63187-465_11589775-58be-49a6-befb-6d24fa830899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074821
Marketing category
ANDA
Marketing start
1997-06-05
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25; 37.5 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0J48LPH2THHYDROCHLOROTHIAZIDE58-93-5HYDROCHLOROTHIAZIDE
WS821Z52LQTRIAMTERENE396-01-0TRIAMTERENE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63187-465-306318704653030 CAPSULE in 1 BOTTLE (63187-465-30) 30 capsule2019-01-01NoNoHistorical
63187-465-606318704656060 CAPSULE in 1 BOTTLE (63187-465-60) 60 capsule2019-01-01NoNoHistorical
63187-465-906318704659090 CAPSULE in 1 BOTTLE (63187-465-90) 90 capsule2019-01-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Triamterene and Hydrochlorothiazide Capsules, USPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL3