Envarsus Tablet, Extended Release
NDC Package 68992-3075-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Envarsus (tacrolimus) tablets is tacrolimus is used with other medications to prevent rejection of a kidney transplant. This formulation utilizes a tablet, extended release delivery system. Marketed by Veloxis Pharmaceuticals, Inc, this product is identified by NDC 68992-3075 and is authorized under FDA application NDA206406.

Identification & Billing

NDC Package Code
68992-3075-3
Package Description
1 POUCH in 1 CARTON / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
68992-3075
11-Digit Billing Format
68992307503
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1664434 - tacrolimus 4 MG 24HR Extended Release Tablet
  • RxCUI: 1664434 - 24 HR tacrolimus 4 MG Extended Release Oral Tablet
  • RxCUI: 1664434 - tacrolimus 4 MG (as anhydrous tacrolimus) 24HR Extended Release Tablet
  • RxCUI: 1664440 - Envarsus XR 4 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1664440 - 24 HR tacrolimus 4 MG Extended Release Oral Tablet [Envarsus]

Clinical Specifications

Proprietary Name
Envarsus XR
Non-Proprietary Name
Tacrolimus
Substance Name
Tacrolimus
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TACROLIMUS .75 mg/1
Pharmacologic Class
Usage Information
Tacrolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

Regulatory & Marketing

Labeler Name
Veloxis Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA206406
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2015
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.

J7503
Source: ASP
Tacrol envarsus ex rel oral
HCPCS Dosage 0.25 MG
Units / Pkg 90

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68992-3075). Click a package code to view its specific billing and regulatory data.

68992-3075-1
1 POUCH in 1 CARTON / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 68992-3075-3 identifies a specific commercial package of 1 pouch in 1 carton / 1 bottle, plastic in 1 pouch / 30 tablet, extended release in 1 bottle, plastic of Envarsus XR, a human prescription drug labeled by Veloxis Pharmaceuticals, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, extended release is formulated for oral use and contains tacrolimus 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 Veloxis Pharmaceuticals, Inc on September 01, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tacrolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

How is this Veloxis Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68992307503. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
68992-3075-3
11-Digit CMS (5-4-2)
68992-3075-03

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