AMLODIPINE BESYLATE

Product NDC
68788-7259
11-digit product format
687887259
Labeler code
68788
Product ID
68788-7259_18d712a6-ea21-42a1-9d4d-dd0bd2f4806f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077073
Marketing category
ANDA
Marketing start
2018-09-11
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
3 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
68788-7259-1EA - Each68788-725938beecd6-0a68-413c-92e1-b59c7ef4fe8712018-11-06
68788-7259-3EA - Each68788-72594479b79e-b254-4c2c-91e0-ef42b760aa9212018-11-06
68788-7259-6EA - Each68788-72592ce34b80-79cb-4fd8-9708-06d4875c5f6b12018-11-06
68788-7259-9EA - Each68788-72593da63f68-5a26-4bd0-b146-8699afe2644f12018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7259-168788725901100 TABLET in 1 BOTTLE (68788-7259-1) 100 tablet2018-09-110000-00-00NoNoCurrent
68788-7259-36878872590330 TABLET in 1 BOTTLE (68788-7259-3) 30 tablet2018-09-110000-00-00NoNoCurrent
68788-7259-66878872590660 TABLET in 1 BOTTLE (68788-7259-6) 60 tablet2018-09-110000-00-00NoNoCurrent
68788-7259-96878872590990 TABLET in 1 BOTTLE (68788-7259-9) 90 tablet2018-09-110000-00-00NoNoCurrent