53041-664 NDC - OMEPRAZOLE, SODIUM BICARBONATE

Drug Information

  • Product NDC: 53041-664
  • Proprietary Name: Omeprazole, Sodium bicarbonate
  • Non Proprietary Name: Omeprazole, Sodium bicarbonate
  • Active Ingredient(s): 20 mg/1 OMEPRAZOLE; 1100 mg/1 SODIUM BICARBONATE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE
  • Pharmacy Class(es): Alkalinizing Activity [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Guardian Drug Company
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA212587
Marketing Category: ANDA
Start Marketing Date:5/7/2020

Package Information

No. Package Code Package Description Billing Unit
153041-664-7730 CAPSULE in 1 BOTTLE (53041-664-77)

NDC Record

Field Name Field Value Definition
PRODUCT NDC53041-664The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEOmeprazole, Sodium bicarbonateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEOmeprazole, Sodium bicarbonateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAMEORALIndicates 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 DATE5/7/2020The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAMEANDAThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
APPLICATION NUMBERANDA212587The translation of the dosage form Code submitted by the firm.
LABELER NAMEGuardian Drug CompanyThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
SUBSTANCE NAMEOMEPRAZOLE; SODIUM BICARBONATEName of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH20; 1100 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAlkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] 

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This page was last updated on: 12/6/2025

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