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NDC 82632-699 Zegerid Otc

Omepraole,Sodium Bicarbonate Capsule, Gelatin Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 82632-699?
  5. Zegerid Otc Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
82632-699
Proprietary Name:
Zegerid Otc
Non-Proprietary Name: [1]
Omepraole, Sodium Bicarbonate
Substance Name: [2]
Omeprazole; Sodium Bicarbonate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Riley Consumer Care Llc
    Labeler Code:
    82632
    Product Label ID:
    8d00c19a-d86b-4a2f-8791-b320ad3ca781
    FDA Application Number: [6]
    ANDA201361
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-10-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - BLUE BAND)
    Shape:
    CAPSULE (C48336)
    Size(s):
    23 MM
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 82632-699?

    The NDC code 82632-699 is assigned by the FDA to the product Zegerid Otc which is a human over the counter drug product labeled by Riley Consumer Care Llc. The generic name of Zegerid Otc is omepraole, sodium bicarbonate. The product's dosage form is capsule, gelatin coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 82632-699-01 1 bottle in 1 carton / 14 capsule, gelatin coated in 1 bottle, 82632-699-03 1 bottle in 1 carton / 42 capsule, gelatin coated in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Zegerid Otc?

    •for adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment•swallow 1 capsule with a glass of water at least 1 hour before eating in the morning•take every day for 14 days•do not take more than 1 capsule a day•do not chew or crush the capsule•do not open capsule and sprinkle on food•do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (in needed)•you may repeat a 14-day course every 4 months•do not take for more than 14 days or more often than every 4 months unless directed by a doctor•children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

    What are Zegerid Otc Active Ingredients?

    An 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.
    • OMEPRAZOLE 20 mg/1 - A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
    • SODIUM BICARBONATE 1100 mg/1 - A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.

    Which are Zegerid Otc UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Zegerid Otc Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Zegerid Otc?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 616539 - omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule
    • RxCUI: 616539 - Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule
    • RxCUI: 646344 - Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006
    • RxCUI: 646344 - omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]
    • RxCUI: 646344 - Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An 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.

    [3] What kind of product is this? - 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This 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.

    [8] What is the Marketing Category? - Product 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".