Amlodipine Besylate

Product NDC
60687-496
11-digit product format
606870496
Labeler code
60687
Product ID
60687-496_2251e2e4-cefb-7d15-e063-6394a90a8cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078925
Marketing category
ANDA
Marketing start
2019-08-22
Substance
AMLODIPINE BESYLATE
Active strength
10 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
2026-12-31
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
60687-496-0160687049601100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-496-01) / 1 TABLET in 1 BLISTER PACK (60687-496-11) 100 blister pack2019-08-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine BesylateAmerican Health Packaging2024-09-17HUMAN PRESCRIPTION DRUG LABEL5