OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE

Product NDC
70518-4517
11-digit product format
705184517
Labeler code
70518
Product ID
70518-4517_43431591-01e3-99e0-e063-6294a90a2e74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204801
Marketing category
ANDA
Marketing start
2025-11-10
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 formatDescriptionMarketing startSampleExclude flagStatus
70518-4517-07051845170090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4517-0) 2025-11-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEREMEDYREPACK INC.2025-11-10HUMAN PRESCRIPTION DRUG LABEL1