NDC 0363-1819 Omeprazole
Tablet, Orally Disintegrating, Delayed Release Oral

Product Information

Product Code0363-1819
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
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 FormTablet, Orally Disintegrating, Delayed Release - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration.
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.
Walgreen Company
Labeler Code0363
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.
NDA209400
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.
NDA - A product marketed under an approved 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.
03-01-2018
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.
12-31-2022
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

Usage Information


Product Characteristics

Color(s)RED (C48326 - REDDISH)
ShapeROUND (C48348)
Size(s)9 MM
Imprint(s)20
Score1
Flavor(s)STRAWBERRY (C73417)

Product Packages

NDC 0363-1819-55

Package Description: 3 CARTON in 1 CARTON > 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

NDC 0363-1819-74

Package Description: 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Product Details

Omeprazole is a human over the counter drug product labeled by Walgreen Company. The product's dosage form is tablet, orally disintegrating, delayed release and is administered via oral form.


What are Omeprazole Active Ingredients?

The following is the list of active ingredients in 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MANNITOL (UNII: 3OWL53L36A)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM STEARATE (UNII: QU7E2XA9TG)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • 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.

Omeprazole 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 Tablet)



Omeprazole 20 mg


Purpose



Acid reducer


Use



  • •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 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:

  • •warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • •prescription antifungal or anti-yeast medicines
  • •diazepam (anxiety medicine)
  • •digoxin (heart medicine)
  • •tacrolimus or mycophenolate mofetil (immune system medicines)
  • •prescription antiretrovirals (medicines for HIV infection)
  • •methotrexate (arthritis medicine)

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

    • •take 1 tablet before eating in the morning
    • do not crush or chew tablets
    • •place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
    • •take every day for 14 days
    • •do not take more than 1 tablet a day
    • •do not use for more than 14 days unless directed by your doctor
    • •do not take this medicine with alcohol
    • Repeated 14-Day Course (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); keep product out of high heat and moisture

Inactive Ingredients



amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate


Questions Or Comments?



1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST


Package/Label Principal Display Panel



Omeprazole

DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 20 mg

ACID REDUCER

MELTS IN YOUR MOUTH; DISSOLVES WITHOUT WATER

ORALLY DISINTEGRATING TABLETS

Treats frequent heartburn!

Occurring 2 or more days a week

ACTUAL SIZE

42 TABLETS

THREE 14-DAY COURSES OF TREATMENT

STRAWBERRY FLAVOR


* Please review the disclaimer below.