NDC 73457-415 Aspirin And Omeprazole Delayed-release Tab

Aspirin And Omeprazole

NDC Product Code 73457-415

NDC CODE: 73457-415

Proprietary Name: Aspirin And Omeprazole Delayed-release Tab 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.

Non-Proprietary Name: Aspirin And Omeprazole 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.

NDC Code Structure

  • 73457 - Innovida Therapeutique Corporation
    • 73457-415 - Aspirin And Omeprazole Delayed-release Tab

NDC 73457-415-80

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Aspirin And Omeprazole Delayed-release Tab with NDC 73457-415 is a a human prescription drug product labeled by Innovida Therapeutique Corporation. The generic name of Aspirin And Omeprazole Delayed-release Tab is aspirin and omeprazole. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Innovida Therapeutique Corporation

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug 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.

Aspirin And Omeprazole Delayed-release Tab Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ASPIRIN 81 mg/1
  • OMEPRAZOLE 40 mg/1

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Platelet Aggregation - [PE] (Physiologic Effect)
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Decreased Prostaglandin Production - [PE] (Physiologic Effect)
  • Anti-Inflammatory Agents -
  • Non-Steroidal - [CS]
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Innovida Therapeutique Corporation
Labeler Code: 73457
FDA Application Number: NDA205103 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 11-13-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Aspirin and Omeprazole

Aspirin and Omeprazole is pronounced as (as' pir in) (oh me' pray zol)

Why is aspirin and omeprazole medication prescribed?
The combination of aspirin and omeprazole is used to reduce the risk of stroke or heart attack in patients who have had or are at risk of these conditions and are also at...
[Read More]

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Aspirin And Omeprazole Delayed-release Tab Product Label Images