Amlodipine Besylate

Product NDC
60760-614
11-digit product format
607600614
Labeler code
60760
Product ID
60760-614_cdb68210-952f-e8da-e053-2a95a90aec7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA078925
Marketing category
ANDA
Marketing start
2021-09-23
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-614-30EA - Each60760-614bc656923-3a19-4c7a-afb0-3f1174a62a6c12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-614AMLODIPINE BESYLATE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20211012_cdb68210-952e-e8da-e053-2a95a90aec7e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-614-306076006143030 TABLET in 1 BOTTLE, PLASTIC (60760-614-30) 30 tablet2021-09-230000-00-00NoNoCurrent