OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product NDC
70518-4577
11-digit product format
705184577
Labeler code
70518
Product ID
70518-4577_4bcf5d09-f53f-876d-e063-6294a90af714
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207037
Marketing category
ANDA
Marketing start
2026-02-27
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
2027-12-31
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
70518-4577-07051845770090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4577-0) 2026-02-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.2026-02-27HUMAN PRESCRIPTION DRUG LABEL1