Home NDC 53808-1120 Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
Product NDC 53808-1120
11-digit product format 538081120
Labeler code 53808
Product ID 53808-1120_7c89cbae-fd36-4723-b4df-e0d71f786070
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DOH CENTRAL PHARMACY
Application NDA200175
Marketing category NDA
Marketing start 2018-10-25
Marketing end 0000-00-00
Substance OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Active strength 20 mg/1; mg/1; mg/1
Pharmacologic classes Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-1120-1 Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-1120 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20190122_852df50b-14bb-408f-b9c2-2cb708d24d76.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53808-1120-1 53808112001 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1120-1) 2018-10-25 0000-00-00 No No Current