NDC Package 42385-946-01 Ursodiol

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

42385-946-01

Package Description:

100 CAPSULE in 1 BOTTLE

Product Code:

42385-946

Proprietary Name:

Ursodiol

Non-Proprietary Name:

Ursodiol

Substance Name:

Ursodiol

Usage Information:

Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones from forming in obese patients who are losing weight rapidly, and to treat a certain type of liver disease (primary biliary cholangitis). Ursodiol is a bile acid.

11-Digit NDC Billing Format:

42385094601

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

NDC to RxNorm Crosswalk:

RxCUI: 858747 - ursodiol 300 MG Oral Capsule

Product Type:

Human Prescription Drug

Labeler Name:

Laurus Labs Limited

Dosage Form:

Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

URSODIOL 300 mg/1

Pharmacologic Class(es):

Bile Acid - [EPC] (Established Pharmacologic Class)

Bile Acids and Salts - [CS]

Sample Package:

FDA Application Number:

ANDA213200

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-17-2021

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

42385 - Laurus Labs Limited
- 42385-946 - Ursodiol
  - 42385-946-01 - 100 CAPSULE 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.

Frequently Asked Questions

What is NDC 42385-946-01?

The NDC Packaged Code 42385-946-01 is assigned to a package of 100 capsule in 1 bottle of Ursodiol, a human prescription drug labeled by Laurus Labs Limited. The product's dosage form is capsule and is administered via oral form.

Is NDC 42385-946 included in the NDC Directory?

Yes, Ursodiol with product code 42385-946 is active and included in the NDC Directory. The product was first marketed by Laurus Labs Limited on April 17, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 42385-946-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 42385-946-01?

The 11-digit format is 42385094601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	42385-946-01	5-4-2	42385-0946-01

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