Famotidine Powder, For Suspension
NDC Package 42571-433-45

11-digit billing NDC: 42571043345 · Billing unit: ML · 50 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Famotidine powders is famotidine for oral suspension is indicated in adults for the treatment of:active duodenal ulcer (DU).active gastric ulcer (GU).symptomatic nonerosive gastroesophageal reflux disease (GERD).erosive esophagitis due to GERD, diagnosed by biopsy.treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).reduction of the risk of DU recurrence.Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of:peptic ulcer disease.GERD with or without esophagitis and ulcerations.Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:GERD. This formulation utilizes a powder, for suspension delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-433 and is authorized under FDA application ANDA217842.

Identification & Billing

NDC Package Code
42571-433-45
Package Description
50 mL in 1 BOTTLE
Product Code
42571-433
11-Digit Billing Format
42571043345
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
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 for oral suspension is indicated in adults for the treatment of:active duodenal ulcer (DU).active gastric ulcer (GU).symptomatic nonerosive gastroesophageal reflux disease (GERD).erosive esophagitis due to GERD, diagnosed by biopsy.treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).reduction of the risk of DU recurrence.Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of:peptic ulcer disease.GERD with or without esophagitis and ulcerations.Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:GERD.

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217842
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2023
Listing Expiration
12-31-2027
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 42571-433-45 identifies a specific commercial package of 50 ml in 1 bottle of Famotidine, a human prescription drug labeled by Micro Labs Limited. 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 Micro Labs Limited on December 01, 2023. The current certification is valid through December 31, 2027.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571043345. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 total billable units per package. 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)
42571-433-45
11-Digit CMS (5-4-2)
42571-0433-45

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