76420-806 NDC - PANTOPRAZOLE SODIUM

Drug Information

Product NDC: 76420-806
Proprietary Name: Pantoprazole Sodium
Non Proprietary Name: Pantoprazole Sodium
Active Ingredient(s): 40 mg/1 PANTOPRAZOLE SODIUM
Administration Route(s): ORAL
Dosage Form(s): TABLET, DELAYED RELEASE
Pharmacy Class(es): Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]

Labeler Information

Field Name	Field Value
Labeler Name:	Asclemed USA, Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA202038
Marketing Category:	ANDA
Start Marketing Date:	9/28/2012

Package Information

No.	Package Code	Package Description	Billing Unit
1	76420-806-10	10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-10)
2	76420-806-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-30)
3	76420-806-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-60)
4	76420-806-90	90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-90)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	76420-806	The 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.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG
PROPRIETARY NAME	Pantoprazole Sodium	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Pantoprazole Sodium	The 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.
DOSAGE FORM NAME	TABLET, DELAYED RELEASE	Indicates 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.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	9/28/2012	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
APPLICATION NUMBER	ANDA202038	The translation of the dosage form Code submitted by the firm.
LABELER NAME	Asclemed USA, Inc.	The translation of the route code submitted by the firm, indicating route of administration.
SUBSTANCE NAME	PANTOPRAZOLE SODIUM	This is the date that the labeler indicates was the start of its marketing of the drug product.
ACTIVE NUMERATOR STRENGTH	40
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]

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This page was last updated on: 11/21/2025

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