Metformin Hydrochloride Tablet
NDC Package 43353-982-30

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

Package Information

Metformin Hydrochloride tablets is metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. This formulation utilizes a tablet delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-982 and is authorized under FDA application ANDA203769.

Identification & Billing

NDC Package Code
43353-982-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
43353-982
11-Digit Billing Format
43353098230
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
Non-Proprietary Name
Metformin Hydrochloride
Substance Name
Metformin Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METFORMIN HYDROCHLORIDE 500 mg/1
Pharmacologic Class
Usage Information
Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203769
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-11-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43353-982). Click a package code to view its specific billing and regulatory data.

43353-982-53
60 TABLET in 1 BOTTLE
43353-982-60
90 TABLET in 1 BOTTLE
43353-982-70
120 TABLET in 1 BOTTLE
43353-982-80
180 TABLET in 1 BOTTLE
43353-982-92
270 TABLET in 1 BOTTLE
43353-982-94
360 TABLET in 1 BOTTLE
43353-982-96
450 TABLET in 1 BOTTLE

* 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 43353-982-30 identifies a specific commercial package of 30 tablet in 1 bottle of Metformin Hydrochloride, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This tablet 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 Aphena Pharma Solutions - Tennessee, Llc on September 11, 2013. The current certification is valid through December 31, 2027.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353098230. 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)
43353-982-30
11-Digit CMS (5-4-2)
43353-0982-30

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