Famotidine Powder, For Suspension
NDC Package 68475-400-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Famotidine powders is famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This formulation utilizes a powder, for suspension delivery system. Marketed by Navinta Llc, this product is identified by NDC 68475-400 and is authorized under FDA application ANDA091020.

Identification & Billing

NDC Package Code
68475-400-01
Package Description
50 mL in 1 BOTTLE, PLASTIC
Product Code
68475-400
11-Digit Billing Format
68475040001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Famotidine
Non-Proprietary Name
Famotidine
Substance Name
Famotidine
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FAMOTIDINE 40 mg/5mL
Pharmacologic Class
Usage Information
Famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Famotidine belongs to a class of drugs known as H2 blockers. This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

Regulatory & Marketing

Labeler Name
Navinta Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA091020
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-22-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68475-400-01 identifies a specific commercial package of 50 ml in 1 bottle, plastic of Famotidine, a human prescription drug labeled by Navinta Llc. This powder, for suspension is formulated for oral use and contains famotidine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Navinta Llc on April 22, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Famotidine belongs to a class of drugs known as H2 blockers. This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

How is this Navinta Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68475040001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68475-400-01
11-Digit CMS (5-4-2)
68475-0400-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.