68645-492 NDC - PANTOPRAZOLE SODIUM ()

Drug Information

  • Product NDC: 68645-492
  • Proprietary Name: Pantoprazole Sodium
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Legacy Pharmaceutical Packaging, LLC
Product Type:
FDA Application Number: ANDA078281
Marketing Category: ANDA
Start Marketing Date:1/20/2011
End Marketing Date:9/30/2018

Package Information

No. Package Code Package Description Billing Unit
168645-492-5430 TABLET, DELAYED RELEASE in 1 BOTTLE (68645-492-54)EA
268645-492-7030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68645-492-70)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC68645-492The 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 NAMEPantoprazole SodiumIndicates 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 DATE1/20/2011The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
END MARKETING DATE1/31/2022The 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 NUMBERANDA078281The translation of the route code submitted by the firm, indicating route of administration.
LABELER NAMELegacy Pharmaceutical Packaging, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC68645-492The 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 NAMEPantoprazole SodiumThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/20/2011Name of Company corresponding to the labeler code segment of the Product NDC.
END MARKETING DATE9/30/2018An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
MARKETING CATEGORY NAMEANDA 
APPLICATION NUMBERANDA078281 
LABELER NAMELegacy Pharmaceutical Packaging, LLC 

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This page was last updated on: 1/16/2026

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