Hydrochlorothiazide

Product NDC
50436-3922
11-digit product format
504363922
Labeler code
50436
Product ID
50436-3922_e3d78a24-d4e9-4790-b2be-82cd74c5bca0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA084325
Marketing category
ANDA
Marketing start
2007-05-01
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
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 productproduct50436-3922DDiscontinued by firm2026-07-31
excluded packagepackage50436-392250436-3922-1DDiscontinued by firm2026-07-31
excluded packagepackage50436-392250436-3922-3DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084325-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALApproved before 1982