Olmesartan Medoxomil and Hydrochlorothiazide

Product NDC
70518-2834
11-digit product format
705182834
Labeler code
70518
Product ID
70518-2834_d76ee54d-814a-2283-e053-2a95a90ab8d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208847
Marketing category
ANDA
Marketing start
2020-08-17
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
13 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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2834-02022-02-07C16284748780-1d6a99b39-5fb5-a426-e053-dadaa90af4c288f0a63d-b084-4ce1-bcbd-dc34082317b9
70518-2834-02022-01-28C16284748780-1d6a99b39-5fb5-a426-e053-dadaa90af4c288f0a63d-b084-4ce1-bcbd-dc34082317b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2834-07051828340090 TABLET in 1 BOTTLE, PLASTIC (70518-2834-0) 90 tablet2020-08-170000-00-00NoNoCurrent