Sular Tablet, Film Coated, Extended Release
NDC Package 70515-503-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sular (nisoldipine) tablets is nisoldipine is used with or without other medications to treat high blood pressure (hypertension). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Covis Pharma Us, Inc, this product is identified by NDC 70515-503 and is authorized under FDA application NDA020356.

Identification & Billing

NDC Package Code
70515-503-10
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
70515-503
11-Digit Billing Format
70515050310
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: 763519 - nisoldipine 17 MG 24HR Extended Release Oral Tablet
  • RxCUI: 763519 - 24 HR nisoldipine 17 MG Extended Release Oral Tablet
  • RxCUI: 763519 - nisoldipine 17 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 763521 - Sular 17 MG 24HR Extended Release Oral Tablet
  • RxCUI: 763521 - 24 HR nisoldipine 17 MG Extended Release Oral Tablet [Sular]

Clinical Specifications

Proprietary Name
Sular
Non-Proprietary Name
Nisoldipine
Substance Name
Nisoldipine
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NISOLDIPINE 34 mg/1
Pharmacologic Class
Usage Information
Nisoldipine is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Nisoldipine is called a calcium channel blocker. It works by relaxing blood vessels so blood can flow more easily.

Regulatory & Marketing

Labeler Name
Covis Pharma Us, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA020356
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-03-2017
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70515-503-10 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet, film coated, extended release in 1 bottle of Sular, a human prescription drug labeled by Covis Pharma Us, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated, extended release is formulated for oral use and contains nisoldipine 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 February 03, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Nisoldipine is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Nisoldipine is called a calcium channel blocker. It works by relaxing blood vessels so blood can flow more easily.

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: 70515050310. 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 (5-3-2)
70515-503-10
11-Digit CMS (5-4-2)
70515-0503-10

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