Amlodipine Besylate

Product NDC
68071-2520
11-digit product format
680712520
Labeler code
68071
Product ID
68071-2520_1885021d-6fe5-9a81-e063-6394a90aba9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078925
Marketing category
ANDA
Marketing start
2010-10-20
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
68071-2520-96807125200990 TABLET in 1 BOTTLE (68071-2520-9) 90 tablet2021-08-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine BesylateNuCare Pharmaceuticals,Inc.2024-05-15HUMAN PRESCRIPTION DRUG LABEL2