Methscopolamine Bromide Tablet
NDC Package 76385-101-60

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

Package Information

Methscopolamine Bromide tablets is methscopolamine is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This formulation utilizes a tablet delivery system. Marketed by Unichem Pharmaceuticals (usa), Inc., this product is identified by NDC 76385-101 and is authorized under FDA application ANDA200602.

Identification & Billing

NDC Package Code
76385-101-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
76385-101
11-Digit Billing Format
76385010160
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methscopolamine Bromide
Non-Proprietary Name
Methscopolamine Bromide
Substance Name
Methscopolamine Bromide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHSCOPOLAMINE BROMIDE 5 mg/1
Pharmacologic Class
Usage Information
Methscopolamine is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Methscopolamine works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Methscopolamine belongs to a class of drugs known as anticholinergics.

Regulatory & Marketing

Labeler Name
Unichem Pharmaceuticals (usa), Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200602
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76385-101-60 identifies a specific commercial package of 60 tablet in 1 bottle of Methscopolamine Bromide, a human prescription drug labeled by Unichem Pharmaceuticals (usa), Inc.. This tablet is formulated for oral use and contains methscopolamine bromide 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 Unichem Pharmaceuticals (usa), Inc. on October 01, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Methscopolamine is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Methscopolamine works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Methscopolamine belongs to a class of drugs known as anticholinergics.

How is this Unichem Pharmaceuticals (usa), Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76385010160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
76385-101-60
11-Digit CMS (5-4-2)
76385-0101-60

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