Metformin Hydrochloride Oral Solution
NDC Package 71656-017-04

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

Package Information

Metformin Hydrochloride Oral Solution (metformin hydrochloride) solution is metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. This formulation utilizes a solution delivery system. Marketed by Saptalis Pharmaceuticals, Llc., this product is identified by NDC 71656-017 and is authorized under FDA application ANDA211309.

Identification & Billing

NDC Package Code
71656-017-04
Package Description
118 mL in 1 BOTTLE
Product Code
71656-017
11-Digit Billing Format
71656001704
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metformin Hydrochloride Oral Solution
Non-Proprietary Name
Metformin Hydrochloride
Substance Name
Metformin Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METFORMIN HYDROCHLORIDE 500 mg/5mL
Pharmacologic Class
Usage Information
Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Saptalis Pharmaceuticals, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211309
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2024
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 71656-017-04 identifies a specific commercial package of 118 ml in 1 bottle of Metformin Hydrochloride Oral Solution, a human prescription drug labeled by Saptalis Pharmaceuticals, Llc.. This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package. This solution is formulated for oral use and contains metformin hydrochloride 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 Saptalis Pharmaceuticals, Llc. on July 31, 2024. The current certification is valid through December 31, 2026.

How is this Saptalis Pharmaceuticals, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71656001704. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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)
71656-017-04
11-Digit CMS (5-4-2)
71656-0017-04

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