Acid Reducer Tablet, Delayed Release
NDC 83324-287
Omeprazole Magnesium 20 mg/1 · Tablet, Delayed Release (oral)
Product Information
This code was recently added to the official NDC directory and the product has entered commercial distribution.
Acid Reducer (omeprazole) is a ANDA-approved product labeled by Chain Drug Marketing Association, Inc.. This medication is typically used as a cytochrome p450 2c19 inhibitors [moa]. It is supplied as a tablet, delayed release for oral administration. This product entry covers the primary NDC 83324-287 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
83324-287
Proprietary Name:
Acid Reducer
Non-Proprietary Name: [1]
Omeprazole
Substance Name: [2]
Omeprazole Magnesium
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet, Delayed Release
- A solid dosage form 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:
83324
Product Label ID:
FDA Application Number: [6]
ANDA206877
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
10-22-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 83324-287?
The NDC code 83324-287 is assigned by the FDA to the product Acid Reducer. It is commonly known by its generic name, omeprazole. This pharmaceutical product is labeled by Chain Drug Marketing Association, Inc. and is currently categorized as listed product. The medication is a tablet, delayed release administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 83324-287-14, 83324-287-42. 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?
For adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentswallow 1 tablet with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 tablet a daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew or crush tablets.Repeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
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.
- OMEPRAZOLE MAGNESIUM 20 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.
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".
