Amlodipine Besylate

Product NDC
50090-6877
11-digit product format
500906877
Labeler code
50090
Product ID
50090-6877_284221d6-4e43-46b1-9ddf-c6f19bfce2af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203245
Marketing category
ANDA
Marketing start
2019-05-22
Substance
AMLODIPINE BESYLATE
Active strength
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
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
50090-6877-05009068770090 TABLET in 1 BOTTLE (50090-6877-0) 90 tablet2023-12-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine BesylateA-S Medication Solutions2024-10-09HUMAN PRESCRIPTION DRUG LABEL3