Amlodipine Besylate

Product NDC
71205-506
11-digit product format
712050506
Labeler code
71205
Product ID
71205-506_3149962f-3daa-456b-867c-dc17b505828f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203245
Marketing category
ANDA
Marketing start
2019-05-22
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
71205-506-307120505063030 TABLET in 1 BOTTLE, PLASTIC (71205-506-30) 30 tablet2020-11-18NoNoHistorical
71205-506-607120505066060 TABLET in 1 BOTTLE, PLASTIC (71205-506-60) 60 tablet2020-11-18NoNoHistorical
71205-506-907120505069090 TABLET in 1 BOTTLE, PLASTIC (71205-506-90) 90 tablet2020-11-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine BesylateProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL2