Lisinopril and Hydrochlorothiazide

Product NDC
53002-1308
11-digit product format
530021308
Labeler code
53002
Product ID
53002-1308_9d89497d-36b5-4381-852e-91dec298c637
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076194
Marketing category
ANDA
Marketing start
2002-07-01
Marketing end
0000-00-00
Substance
LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength
10 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
E7199S1YWRLISINOPRIL83915-83-7LISINOPRIL
0J48LPH2THHYDROCHLOROTHIAZIDE58-93-5HYDROCHLOROTHIAZIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1308-053002130800100 TABLET in 1 BOTTLE (53002-1308-0) 100 tablet2020-01-010000-00-00NoNoCurrent
53002-1308-35300213080330 TABLET in 1 BOTTLE (53002-1308-3) 30 tablet2020-01-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USPRPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL3