NDC product

Amlodipine and atorvastatin

NDC 0378-4515 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-4515
Proprietary name Amlodipine and atorvastatin
Nonproprietary name Amlodipine and atorvastatin
Substances AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA200465
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC] and 1 more
Marketing start Oct 16, 2014
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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