Olmesartan Medoxomil and Hydrochlorothiazide

Product NDC
63629-4307
11-digit product format
636294307
Labeler code
63629
Product ID
63629-4307_4260e974-b777-48b2-9ec2-af8e91e2ef6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204233
Marketing category
ANDA
Marketing start
2017-04-24
Substance
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
25; 40 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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
6M97XTV3HDOLMESARTAN MEDOXOMIL144689-63-4OLMESARTAN MEDOXOMIL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4307-16362943070190 TABLET in 1 BOTTLE (63629-4307-1) 90 tablet2024-06-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Olmesartan Medoxomil and HydrochlorothiazideBryant Ranch Prepack2024-06-26HUMAN PRESCRIPTION DRUG LABEL1