DYAZIDE

Product NDC
65084-135
11-digit product format
650840135
Labeler code
65084
Product ID
65084-135_a0053182-dd25-4095-baa2-6683b4cd7b95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrochlorothiazide and triamterene
Dosage form
CAPSULE
Route
ORAL
Labeler
Mckesson Rxpak Inc
Application
NDA016042
Marketing category
NDA
Marketing start
1994-03-30
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct65084-135DDiscontinued by firm2026-07-31
excluded packagepackage65084-13565084-135-10DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016042-002DYAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982
N016042-003DYAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-03-03