Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 0310-6325-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Dapagliflozin And Metformin Hydrochloride tablets is a drug for further processing. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-6325.

Identification & Billing

NDC Package Code
0310-6325-00
Package Description
180000 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM
Product Code
0310-6325
11-Digit Billing Format
00310632500

Clinical Specifications

Proprietary Name
Dapagliflozin And Metformin Hydrochloride
Non-Proprietary Name
Dapagliflozin And Metformin Hydrochloride
Substance Name
Dapagliflozin Propanediol; Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-19-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 0310-6325-00 identifies a specific commercial package of 180000 tablet, film coated, extended release in 1 drum of Dapagliflozin And Metformin Hydrochloride (UNFINISHED drug), drug for further processing labeled by Astrazeneca Pharmaceuticals Lp. This tablet, film coated, extended release is formulated for use and contains dapagliflozin propanediol; 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 Astrazeneca Pharmaceuticals Lp on May 19, 2022. The current certification is valid through December 31, 2026.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310632500. 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 (4-4-2)
0310-6325-00
11-Digit CMS (5-4-2)
00310-6325-00

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