NDC product

Fosamprenavir Calcium

NDC 0378-3520 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-3520
Proprietary name Fosamprenavir Calcium
Nonproprietary name fosamprenavir calcium
Substances FOSAMPRENAVIR CALCIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA204060
Pharmacologic classes Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]
Marketing start Sep 18, 2017
Listing certified through Dec 31, 2027

At a glance

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About National Drug Codes (NDC)

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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