NDC 0115-9822-02 Digoxin

Digoxin

NDC Package Code 0115-9822-02

The NDC Code 0115-9822-02 is assigned to a package of 500 tablet in 1 bottle of Digoxin, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet and is administered via oral form.

Field Name Field Value
NDC Code 0115-9822-02
Package Description 500 TABLET in 1 BOTTLE
Proprietary Name Digoxin 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 Digoxin 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.
Drug Uses Digoxin is used to treat heart failure, usually along with other medications. It is also used to treat certain types of irregular heartbeat (such as chronic atrial fibrillation). Treating heart failure may help maintain your ability to walk and exercise and may improve the strength of your heart. Treating an irregular heartbeat can also improve your ability to exercise. Digoxin belongs to a class of medications called cardiac glycosides. It works by affecting certain minerals (sodium and potassium) inside heart cells. This reduces strain on the heart and helps it maintain a normal, steady, and strong heartbeat.
11-Digit NDC Billing Format 00115982202 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
RxNorm Crosswalk197604 and 197606 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
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.
Labeler Name Amneal Pharmaceuticals Of New York Llc
Dosage Form Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • DIGOXIN 250 ug/1
Pharmacological Class(es)
  • Cardiac Glycoside - [EPC] (Established Pharmacologic Class)
  • Cardiac Glycosides - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated 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.
FDA Application Number ANDA078556 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.
Start Marketing Date 07-20-2009 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 12-31-2021 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 ("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".

NDC Code Structure

  • 0115 - Amneal Pharmaceuticals Of New York Llc
    • 0115-9822 - Digoxin
      • 0115-9822-02 - 500 TABLET in 1 BOTTLE

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Digoxin with product NDC 0115-9822.

NDC Package CodePackage Description
0115-9822-01100 TABLET in 1 BOTTLE
0115-9822-031000 TABLET in 1 BOTTLE

* Please review the disclaimer below.