NDC Package 0378-3520-91 Fosamprenavir Calcium

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0378-3520-91
Package Description:
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Fosamprenavir Calcium
Non-Proprietary Name:
Fosamprenavir Calcium
Substance Name:
Fosamprenavir Calcium
Usage Information:
This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Fosamprenavir belongs to a class of drugs known as protease inhibitors. It may be given with ritonavir, another protease inhibitor, to increase ("boost") the levels of fosamprenavir. This helps fosamprenavir work better. Fosamprenavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
11-Digit NDC Billing Format:
00378352091
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 402109 - fosamprenavir calcium 700 MG Oral Tablet
  • RxCUI: 402109 - fosamprenavir 700 MG Oral Tablet
  • RxCUI: 402109 - fosamprenavir (as fosamprenavir calcium) 700 MG (amprenavir 600 MG) Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA204060
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-18-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-3520-91?

    The NDC Packaged Code 0378-3520-91 is assigned to a package of 60 tablet, film coated in 1 bottle, plastic of Fosamprenavir Calcium, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

    Is NDC 0378-3520 included in the NDC Directory?

    Yes, Fosamprenavir Calcium with product code 0378-3520 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on September 18, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0378-3520-91?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 0378-3520-91?

    The 11-digit format is 00378352091. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20378-3520-915-4-200378-3520-91