OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE

Product NDC
50090-7127
11-digit product format
500907127
Labeler code
50090
Product ID
50090-7127_f1071429-1749-47d6-8e40-c3fd9e261f1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207804
Marketing category
ANDA
Marketing start
2017-04-24
Substance
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
12.5; 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
50090-7127-05009071270090 TABLET in 1 BOTTLE (50090-7127-0) 90 tablet2024-04-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEA-S Medication Solutions2024-04-10HUMAN PRESCRIPTION DRUG LABEL3