NDC Package 42385-949-19 Metformin Hydrochloride

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

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:
42385-949-19
Package Description:
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
Proprietary Name:
Metformin Hydrochloride
Non-Proprietary Name:
Metformin Hydrochloride
Substance Name:
Metformin Hydrochloride
Usage Information:
Metformin hydrochloride tablets, USP are 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.
11-Digit NDC Billing Format:
42385094919
NDC to RxNorm Crosswalk:
  • RxCUI: 861004 - metFORMIN HCl 1000 MG Oral Tablet
  • RxCUI: 861004 - metformin hydrochloride 1000 MG Oral Tablet
  • RxCUI: 861004 - metformin HCl 1 GM Oral Tablet
  • RxCUI: 861007 - metFORMIN HCl 500 MG Oral Tablet
  • RxCUI: 861007 - metformin hydrochloride 500 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Laurus Labs Limited
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA209882
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-17-2021
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    42385-949-01100 TABLET, FILM COATED in 1 BOTTLE
    42385-949-05500 TABLET, FILM COATED in 1 BOTTLE
    42385-949-111000 TABLET, FILM COATED in 1 BOTTLE
    42385-949-18180 TABLET, FILM COATED in 1 BOTTLE
    42385-949-6060 TABLET, FILM COATED in 1 BOTTLE
    42385-949-9090 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42385-949-19?

    The NDC Packaged Code 42385-949-19 is assigned to a package of 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack of Metformin Hydrochloride, a human prescription drug labeled by Laurus Labs Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 42385-949 included in the NDC Directory?

    Yes, Metformin Hydrochloride with product code 42385-949 is active and included in the NDC Directory. The product was first marketed by Laurus Labs Limited on May 17, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 42385-949-19?

    The 11-digit format is 42385094919. 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
    5-3-242385-949-195-4-242385-0949-19