HYDROCHLOROTHIAZIDE

Product NDC
0615-8449
11-digit product format
006158449
Labeler code
0615
Product ID
0615-8449_9079c505-b8f7-4c45-9602-d4a9b998d910
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCHLOROTHIAZIDE
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040702
Marketing category
ANDA
Marketing start
2019-11-01
Substance
HYDROCHLOROTHIAZIDE
Active strength
12.5 mg/1
Pharmacologic classes
Increased Diuresis [PE], 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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8449-050061584490515 TABLET in 1 BLISTER PACK (0615-8449-05) 15 tablet2024-07-12NoNoHistorical
0615-8449-390061584493930 TABLET in 1 BLISTER PACK (0615-8449-39) 30 tablet2023-03-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROCHLOROTHIAZIDE TABLETS, USP Rx onlyNCS HealthCare of KY, LLC dba Vangard Labs2024-08-12HUMAN PRESCRIPTION DRUG LABEL5