Amlodipine and atorvastatin

Product NDC
0378-4511
11-digit product format
003784511
Labeler code
0378
Product ID
0378-4511_bd2370c0-0e67-4e93-b4cf-08134ba68346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and atorvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA200465
Marketing category
ANDA
Marketing start
2014-06-19
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4511-93EA - Each0378-4511c7c38fb9-b05a-46b9-bd38-86dcfc7da5a012014-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4511-930037845119330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4511-93) 2014-06-190000-00-00NoNoCurrent