Azor

Product NDC
65597-112
11-digit product format
655970112
Labeler code
65597
Product ID
65597-112_d5485e0f-7c18-4073-91f6-0890243d9bd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA022100
Marketing category
NDA
Marketing start
2007-09-26
Marketing end
2023-10-31
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
5 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-112-10EA - Each65597-11207377290-ad67-4371-a93f-06b9b2d3e5b112015-10-02
65597-112-30EA - Each65597-1128008207a-1c8a-4cb6-8e39-469af97c3bb512012-07-24
65597-112-90EA - Each65597-112300d72f9-e542-4354-9dcb-63c92db031db12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65597-112-07655970112077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-112-07) 2007-09-260000-00-00NoNoCurrent
65597-112-106559701121010 BLISTER PACK in 1 BOX (65597-112-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2007-09-260000-00-00NoNoCurrent
65597-112-11655970112111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-112-11) 2007-09-260000-00-00NoNoCurrent
65597-112-306559701123030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-112-30) 2007-09-260000-00-00NoNoCurrent
65597-112-906559701129090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-112-90) 2007-09-260000-00-00NoNoCurrent