AMLODIPINE BESYLATE

Product NDC
68788-6386
11-digit product format
687886386
Labeler code
68788
Product ID
68788-6386_68e72613-063a-4ac0-a52c-831a12ee6c41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077073
Marketing category
ANDA
Marketing start
2016-05-04
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6386-1EA - Each68788-63865b9c2f4d-e430-4a92-91c1-fcfa7da7638312020-05-08
68788-6386-9EA - Each68788-63860dcbf3f7-fb1a-472e-9103-d01bcb0d7bcf12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6386AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS INC.]10Legacy NDC20250124_ce894f35-8942-443b-80ef-46353d2fa3c2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-6386-168788638601100 TABLET in 1 BOTTLE (68788-6386-1) 100 tablet2016-05-040000-00-00NoNoCurrent
68788-6386-36878863860330 TABLET in 1 BOTTLE (68788-6386-3) 30 tablet2016-05-040000-00-00NoNoCurrent
68788-6386-66878863860660 TABLET in 1 BOTTLE (68788-6386-6) 60 tablet2016-05-040000-00-00NoNoCurrent
68788-6386-96878863860990 TABLET in 1 BOTTLE (68788-6386-9) 90 tablet2016-05-040000-00-00NoNoCurrent