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  5. NDC Package Code: 0378-2895-20 Ferric Citrate

NDC Package 0378-2895-20 Ferric Citrate

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
0378-2895-20
Package Description:
200 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0378-2895
Proprietary Name:
Ferric Citrate
Non-Proprietary Name:
Ferric Citrate
Substance Name:
Tetraferric Tricitrate Decahydrate
Usage Information:
Ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool. Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.
11-Digit NDC Billing Format:
00378289520
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
200 EA
NDC to RxNorm Crosswalk:
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):
TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA205874
Marketing Category:
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date:
03-20-2025
Listing Expiration Date:
12-31-2026
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 0378-2895-20?

The NDC Packaged Code 0378-2895-20 is assigned to a package of 200 tablet, film coated in 1 bottle of Ferric Citrate, 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 200 billable units per package.

Is NDC 0378-2895 included in the NDC Directory?

Yes, Ferric Citrate with product code 0378-2895 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on March 20, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0378-2895-20?

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 200.

What is the 11-digit format for NDC 0378-2895-20?

The 11-digit format is 00378289520. 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
4-4-20378-2895-205-4-200378-2895-20