Dapagliflozin Tablet, Film Coated
NDC Package 70377-024-12

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

Dapagliflozin tablets are indicated:To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of UseDapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)].Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. This formulation utilizes a tablet, film coated delivery system. Marketed by Biocon Pharma Inc., this product is identified by NDC 70377-024 and is authorized under FDA application ANDA211470.

Identification & Billing

NDC Package Code
70377-024-12
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
70377-024
11-Digit Billing Format
70377002412
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dapagliflozin
Non-Proprietary Name
Dapagliflozin
Substance Name
Dapagliflozin 2,3-butanediol Monohydrate
Dosage Form
Tablet, Film Coated - 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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE 10 mg/1
Pharmacologic Class
Usage Information
Dapagliflozin tablets are indicated:To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of UseDapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)].Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin tablets are likely to be ineffective in this setting based upon its mechanism of action.Pediatric use information is approved for AstraZeneca AB's Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB's marketing exclusivity rights, this drug product is not labeled with that information.

Regulatory & Marketing

Labeler Name
Biocon Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211470
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2026
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 (70377-024). Click a package code to view its specific billing and regulatory data.

70377-024-11
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 70377-024-12 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle, plastic of Dapagliflozin, a human prescription drug labeled by Biocon Pharma Inc.. This tablet, film coated is formulated for oral use and contains dapagliflozin 2,3-butanediol monohydrate 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 Biocon Pharma Inc. on May 01, 2026. The current certification is valid through December 31, 2027.

How is this Biocon Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70377002412. 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)
70377-024-12
11-Digit CMS (5-4-2)
70377-0024-12

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