Triamterene and Hydrochlorothiazide

Product NDC
63629-4112
11-digit product format
636294112
Labeler code
63629
Product ID
63629-4112_75eaf6c9-b57b-4880-ab58-372c2fa3ac27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA073191
Marketing category
ANDA
Marketing start
1991-07-31
Marketing end
0000-00-00
Substance
TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength
50 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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-4112DDiscontinued by firm2026-07-31
excluded packagepackage63629-411263629-4112-1DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073191-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;50MGCAPSULE / ORAL1991-07-31