NDC 21130-714 Signature Care Esomeprazole Magnesium

Esomeprazole Capsule, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
21130-714
Proprietary Name:
Signature Care Esomeprazole Magnesium
Non-Proprietary Name: [1]
Esomeprazole
Substance Name: [2]
Esomeprazole
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Delayed Release - 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, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Safeway
    Labeler Code:
    21130
    FDA Application Number: [6]
    ANDA207193
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    07-02-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    CAPSULE (C48336)
    Size(s):
    11 MM
    Imprint(s):
    7U4
    Score:
    1

    Product Packages

    NDC Code 21130-714-01

    Package Description: 1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

    NDC Code 21130-714-03

    Package Description: 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

    Product Details

    What is NDC 21130-714?

    The NDC code 21130-714 is assigned by the FDA to the product Signature Care Esomeprazole Magnesium which is a human over the counter drug product labeled by Safeway. The generic name of Signature Care Esomeprazole Magnesium is esomeprazole. The product's dosage form is capsule, delayed release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 21130-714-01 1 bottle in 1 carton / 14 capsule, delayed release in 1 bottle, 21130-714-03 3 bottle in 1 carton / 14 capsule, delayed release 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 Signature Care Esomeprazole Magnesium?

    •adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•may take 1 to 4 days for full effect14-Day Course of Treatment•swallow 1 capsule with a glass of water before eating in the morning•take every day for 14 days•do not take more than 1 capsule a day•swallow whole. Do not crush or chew capsules.•do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if 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 before use. Heartburn in children may sometimes be caused by a serious condition.

    What are Signature Care Esomeprazole Magnesium 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.

    Which are Signature Care Esomeprazole Magnesium UNII Codes?

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

    Which are Signature Care Esomeprazole Magnesium 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 Signature Care Esomeprazole Magnesium?

    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: 606726 - esomeprazole magnesium 20 MG Delayed Release Oral Capsule
    • RxCUI: 606726 - esomeprazole 20 MG Delayed Release Oral Capsule
    • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule
    • RxCUI: 606726 - esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule

    Which are the Pharmacologic Classes for Signature Care Esomeprazole Magnesium?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Esomeprazole


    Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine) in adults. It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Prescription esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Nonprescription (over-the-counter) esomeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
    [Learn More]


    * 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".