OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE

Product NDC
50090-7478
11-digit product format
500907478
Labeler code
50090
Product ID
50090-7478_484e0d7c-f7ca-4aaa-a919-d07f2297c13f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204801
Marketing category
ANDA
Marketing start
2023-06-02
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-7478-05009074780030 TABLET, FILM COATED in 1 BOTTLE (50090-7478-0) 2024-12-19NoNoHistorical
50090-7478-15009074780190 TABLET, FILM COATED in 1 BOTTLE (50090-7478-1) 2024-12-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEA-S Medication Solutions2024-12-27Human Prescription Drug Label3