Triamterene and Hydrochlorothiazide

Product NDC
63187-905
11-digit product format
631870905
Labeler code
63187
Product ID
63187-905_bfe1a860-0657-4f48-9b82-31f9483838c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201407
Marketing category
ANDA
Marketing start
2011-12-12
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
63187-905-306318709053030 CAPSULE in 1 BOTTLE (63187-905-30) 30 capsule2017-09-01NoNoHistorical
63187-905-606318709056060 CAPSULE in 1 BOTTLE (63187-905-60) 60 capsule2017-09-01NoNoHistorical
63187-905-906318709059090 CAPSULE in 1 BOTTLE (63187-905-90) 90 capsule2017-09-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Triamterene and Hydrochlorothiazide Capsules, USP Rx OnlyProficient Rx LP2023-01-01HUMAN PRESCRIPTION DRUG LABEL5