NDC 46122-648 Good Neighbor Pharmacy Esomeprazole Magnesium
Esomeprazole Capsule, Delayed Release Oral

Product Information

Good Neighbor Pharmacy Esomeprazole Magnesium is a human over the counter drug product labeled by Amerisource Bergen. The generic name of Good Neighbor Pharmacy Esomeprazole Magnesium is esomeprazole. The product's dosage form is capsule, delayed release and is administered via oral form.

Product Code46122-648
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Good Neighbor Pharmacy Esomeprazole Magnesium
Non-Proprietary Name 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.
Esomeprazole
Product Type 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.
Human Otc Drug
Dosage FormCapsule, 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Amerisource Bergen
Labeler Code46122
FDA Application Number 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.
ANDA207193
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-24-2020
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Good Neighbor Pharmacy Esomeprazole Magnesium?


Product Characteristics

Color(s)BLUE (C48333 - OPAQUE)
ShapeCAPSULE (C48336)
Size(s)14 MM
Imprint(s)L898
Score1

Product Packages

NDC 46122-648-03

Package Description: 2 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Price per Unit: $0.36080 per EA

NDC 46122-648-04

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

Price per Unit: $0.36080 per EA

NDC 46122-648-74

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

Price per Unit: $0.36080 per EA

Product Details

What are Good Neighbor Pharmacy 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.

NDC to RxNorm Crosswalk

What is RxNorm? 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

Inactive Ingredient(s)

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.
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MEGLUMINE (UNII: 6HG8UB2MUY)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Pharmacologic Class(es)

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.

Good Neighbor Pharmacy Esomeprazole Magnesium Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient (In Each Capsule)



Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)


Purpose



Acid reducer


Uses



  • •treats frequent heartburn (occurs 2 or more days a week)
  • •not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings



Allergy alert: Do not use if you are allergic to esomeprazole


Do Not Use If You Have:



  • •trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • •heartburn with lightheadedness, sweating or dizziness
  • •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • •frequent chest pain
  • These may be signs of a serious condition. See your doctor.


Ask A Doctor Before Use If You Have



  • •had heartburn over 3 months. This may be a sign of a more serious condition.
  • •frequent wheezing, particularly with heartburn
  • •unexplained weight loss
  • •nausea or vomiting
  • •stomach pain

Ask A Doctor Or Pharmacist Before Use If You Are



  • •taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop Use And Ask A Doctor If



  • •your heartburn continues or worsens
  • •you need to take this product for more than 14 days
  • •you need to take more than 1 course of treatment every 4 months
  • •you get diarrhea
  • •you develop a rash or joint pain

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • •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 effect
  • 14-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 doctor
    • Repeated 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.

Other Information



  • •read the directions and warnings before use
  • •keep the carton. It contains important information.
  • •store at 20-25°C (68-77°F)

Inactive Ingredients



FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Nexium® 24 HR active ingredient

See New Warning Information

24 HR

Esomeprazole Magnesium

delayed release capsules, 20 mg

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Capsules

actual size

28 Capsules

two 14-day courses of treatment


* Please review the disclaimer below.