OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE

Product NDC
50090-6836
11-digit product format
500906836
Labeler code
50090
Product ID
50090-6836_f90198a3-6e81-4be0-b0ae-f9c982151afa
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; 20 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
50090-6836-05009068360030 TABLET in 1 BOTTLE (50090-6836-0) 30 tablet2023-11-21NoNoHistorical
50090-6836-15009068360190 TABLET in 1 BOTTLE (50090-6836-1) 90 tablet2023-11-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEA-S Medication Solutions2023-11-29HUMAN PRESCRIPTION DRUG LABEL2