Esomeprazole Magnesium Capsule, Delayed Release
NDC 80425-0331
Esomeprazole Magnesium 40 mg/1 · Capsule, Delayed Release (oral)
Product Information
Esomeprazole Magnesium is a ANDA-approved product labeled by Advanced Rx Pharmacy Of Tennessee, Llc. This medication is typically used as a cytochrome p450 2c19 inhibitors [moa]. It is supplied as a white capsule, delayed release for oral administration. This product entry covers the primary NDC 80425-0331 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
80425-0331
Proprietary Name:
Esomeprazole Magnesium DR
Non-Proprietary Name: [1]
Esomeprazole Magnesium
Substance Name: [2]
Esomeprazole Magnesium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
80425
Product Label ID:
FDA Application Number: [6]
ANDA211977
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
05-02-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
H;E3 Score:
1
Code Structure Chart
Product Details
What is NDC 80425-0331?
The NDC code 80425-0331 is assigned by the FDA to the product Esomeprazole Magnesium DR. This pharmaceutical product is labeled by Advanced Rx Pharmacy Of Tennessee, Llc and is currently categorized as listed product. The medication is a capsule, delayed release administered via oral route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 80425-0331-1, 80425-0331-2, 80425-0331-3. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
1.1 Healing of Erosive Esophagitis (EE)AdultsEsomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered.Pediatric Patients 12 Years to 17 Years of AgeEsomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.1.2 Maintenance of Healing of EEEsomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.1.3 Treatment of Symptomatic GERDAdultsEsomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.Pediatric Patients 12 Years to 17 Years of AgeEsomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric UlcerEsomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceEradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.Triple TherapyEsomeprazole magnesium delayed-release capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology ( 12.4) and the prescribing information for clarithromycin].1.6 Pathological Hypersecretory Conditions Including Zollinger-Ellison SyndromeEsomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.
What are Active Ingredients of this product?
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.
- ESOMEPRAZOLE MAGNESIUM 40 mg/1 - The S-isomer of omeprazole.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9)
- ESOMEPRAZOLE (UNII: N3PA6559FT) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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: 606730 - esomeprazole magnesium 40 MG Delayed Release Oral Capsule
- RxCUI: 606730 - esomeprazole 40 MG Delayed Release Oral Capsule
- RxCUI: 606730 - esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule
Which are the Pharmacologic Classes of this product?
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.
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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
