Amlodipine Besylate

Product NDC
55154-8093
11-digit product format
551548093
Labeler code
55154
Product ID
55154-8093_3e9e049d-a988-4dc5-b9aa-14f1162409d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078226
Marketing category
ANDA
Marketing start
2013-01-20
Substance
AMLODIPINE BESYLATE
Active strength
2.5 mg/1
Pharmacologic classes
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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
864V2Q084HAMLODIPINE BESYLATE111470-99-6AMLODIPINE BESYLATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-8093-05515480930010 BLISTER PACK in 1 BAG (55154-8093-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2013-01-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine BesylateCardinal Health 107, LLC2026-04-09HUMAN PRESCRIPTION DRUG LABEL18