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  5. NDC Package Code: 66993-362-30 Dapagliflozin And Metformin Hydrochloride

NDC Package 66993-362-30 Dapagliflozin And Metformin Hydrochloride

Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
66993-362-30
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
66993-362
Proprietary Name:
Dapagliflozin And Metformin Hydrochloride
Non-Proprietary Name:
Dapagliflozin And Metformin Hydrochloride
Substance Name:
Dapagliflozin Propanediol; Metformin Hydrochloride
Usage Information:
Dapagliflozin and Metformin HCl extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Dapagliflozin is indicated to reduce•the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.•the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.•the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.Limitations of Use•Dapagliflozin and Metformin HCl extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2)].•Because of the metformin component, the use of Dapagliflozin and Metformin HCl extended-release tablets are limited to adults with type 2 diabetes mellitus for all indications.•Dapagliflozin and Metformin HCl extended-release tablets are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dapagliflozin and Metformin HCl extended-release tablets not expected to be effective in these populations.
11-Digit NDC Billing Format:
66993036230
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1593058 - dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1593058 - 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
  • RxCUI: 1593058 - dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1593070 - dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1593070 - 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Prasco, Llc
    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.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DAPAGLIFLOZIN PROPANEDIOL 10 mg/1
  • METFORMIN HYDROCHLORIDE 1000 mg/1
    • Pharmacologic Class(es):
  • Biguanide - [EPC] (Established Pharmacologic Class)
  • Biguanides - [CS]
  • Sodium-Glucose Cotransporter 2 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Sodium-Glucose Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA205649
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    01-03-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 66993-362-30?

    The NDC Packaged Code 66993-362-30 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle, plastic of Dapagliflozin And Metformin Hydrochloride, a human prescription drug labeled by Prasco, Llc. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 66993-362 included in the NDC Directory?

    Yes, Dapagliflozin And Metformin Hydrochloride with product code 66993-362 is active and included in the NDC Directory. The product was first marketed by Prasco, Llc on January 03, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 66993-362-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 66993-362-30?

    The 11-digit format is 66993036230. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-266993-362-305-4-266993-0362-30