NDC 46122-686 Omeprazole
Capsule, Delayed Release Oral

Product Information

What is NDC 46122-686?

The NDC code 46122-686 is assigned by the FDA to the product Omeprazole which is a human over the counter drug product labeled by Amerisource Bergen. The product's dosage form is capsule, delayed release and is administered via oral form. The product is distributed in a single package with assigned NDC code 46122-686-03 2 bottle in 1 blister pack / 14 capsule, delayed release in 1 bottle (46122-686-74). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code46122-686
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.		Omeprazole
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.		Omeprazole
Substance Name 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.		Omeprazole Magnesium
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.		ANDA210593
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.		03-31-2021
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 Omeprazole?


Product Characteristics

Color(s)PINK (C48328)
ShapeCAPSULE (C48336)
Size(s)18 MM
Imprint(s)RG49
Score1

Product Packages

NDC Code 46122-686-03

Package Description: 2 BOTTLE in 1 BLISTER PACK / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74)

Price per Unit: $0.36791 per EA

Product Details

What are Omeprazole 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 MAGNESIUM 20.6 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.

Omeprazole Active Ingredients UNII Codes

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: 198051 - omeprazole 20 MG Delayed Release Oral Capsule
  • RxCUI: 198051 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule

Omeprazole 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.

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.

Patient Education

Omeprazole


Prescription omeprazole is used alone or with other medications 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 omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole 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.

Omeprazole Product Label

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.

Product Label Table of Contents



Active Ingredient (In Each Capsule)



*Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)


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 omeprazole

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



  • •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; some people get complete relief of symptoms within 24 hours

    • 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
    • •do not use for more than 14 days unless directed by your doctor
    • •swallow whole. Do not chew or crush capsules.

      • 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. 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). [See USP controlled room temperature]. Protect from moisture

Inactive Ingredients



FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate


Questions?



Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984.

Distributed By:

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428


Package/Label Principal Display Panel



†Compare To Prilosec OTC®

active ingredient

NDC 46122-686-03

2x14 COUNT BOTTLE INSIDE

Treats FREQUENT Heartburn!

24

HR

Omeprazole

Delayed-release Capsules

20 mg* / Acid Reducer

ohm®

28 CAPSULES

Two 14-day courses of treatment

May take 1 to 4 days for full effect

spl-gnp-omeprazole-caps - spl gnp omeprazole caps

spl-gnp-omeprazole-caps - spl gnp omeprazole caps


* Please review the disclaimer below.