0603-4469 NDC - METFORMIN HYDROCHLORIDE ()

Drug Information

  • Product NDC: 0603-4469
  • Proprietary Name: Metformin Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Qualitest Pharmaceuticals
Product Type:
FDA Application Number: ANDA077853
Marketing Category: ANDA
Start Marketing Date:7/28/2006
End Marketing Date:9/30/2013

Package Information

No. Package Code Package Description Billing Unit
10603-4469-0920 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-4469-09)
20603-4469-21100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-4469-21)EA
30603-4469-28500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-4469-28)EA
40603-4469-321000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-4469-32)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0603-4469The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEMetformin HydrochlorideIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
START MARKETING DATE7/28/2006A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
END MARKETING DATE9/30/2013The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
MARKETING CATEGORY NAMEANDAThe translation of the dosage form Code submitted by the firm.
APPLICATION NUMBERANDA077853The translation of the route code submitted by the firm, indicating route of administration.
LABELER NAMEQualitest PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 1/2/2026