NDC 70515-261-10 Lanoxin

Digoxin

NDC Package Code 70515-261-10

The NDC Code 70515-261-10 is assigned to a package of 10 vial in 1 box > 2 ml in 1 vial of Lanoxin, a human prescription drug labeled by Covis Pharma Us, Inc. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 20 billable units per package.

Field Name	Field Value
NDC Code	70515-261-10
Package Description	10 VIAL in 1 BOX > 2 mL in 1 VIAL
Proprietary Name	Lanoxin 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	70515026110 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.
Billing Unit	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package	20 ML
RxNorm Crosswalk	104208, 204504, 208135 and 208137 - RxCUI 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	Covis Pharma Us, Inc
Dosage Form	Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s)	Intramuscular - Administration within a muscle. Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)	DIGOXIN 250 ug/mL
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	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.
FDA Application Number	NDA009330 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	10-29-2019 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	12-31-2022 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

70515 - Covis Pharma Us, Inc
- 70515-261 - Lanoxin
  - 70515-261-10 - 10 VIAL in 1 BOX

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.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 70515-261-10 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
70515026110	J1160	Digoxin injection	0.5 MG	2	10	1	10

* Please review the disclaimer below.

Previous Code: 70515-260

Next Code: 70515-262