Lanoxin Injection, Solution
NDC Package 70515-260-10

11-digit billing NDC: 70515026010 · Billing unit: ML · 20 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Lanoxin (digoxin) injection is lANOXIN is contraindicated in patients with:Ventricular fibrillation [see Warnings and Precautions ( 5.1)] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). This formulation utilizes a injection, solution delivery system. Marketed by Covis Pharma Us, Inc, this product is identified by NDC 70515-260 and is authorized under FDA application NDA009330.

Identification & Billing

NDC Package Code
70515-260-10
Package Description
10 AMPULE in 1 BOX / 2 mL in 1 AMPULE
Product Code
70515-260
11-Digit Billing Format
70515026010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
20 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lanoxin
Non-Proprietary Name
Digoxin
Substance Name
Digoxin
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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DIGOXIN 250 ug/mL
Pharmacologic Class
Usage Information
LANOXIN is contraindicated in patients with:Ventricular fibrillation [see Warnings and Precautions ( 5.1)] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.

Regulatory & Marketing

Labeler Name
Covis Pharma Us, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA009330
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-15-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1160
Source: ASP
Digoxin injection
HCPCS Dosage 0.5 MG
Units / Pkg 10

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70515-260-10 identifies a specific commercial package of 10 ampule in 1 box / 2 ml in 1 ampule of Lanoxin, a human prescription drug labeled by Covis Pharma Us, Inc. This product is billed per "ML" milliliter and contains an estimated amount of 20 billable units per package. This injection, solution is formulated for intramuscular; intravenous use and contains digoxin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Covis Pharma Us, Inc on September 15, 2017. The current certification is valid through December 31, 2026.

How is this Covis Pharma Us, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70515026010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 20 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70515-260-10
11-Digit CMS (5-4-2)
70515-0260-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.