Donnatal Tablet
NDC Package 59212-425-04

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

Package Information

Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide) tablets is this product contains several medications: belladonna alkaloids (made up of the drugs hyoscyamine, atropine, and scopolamine) and phenobarbital. This formulation utilizes a tablet delivery system. Marketed by Advanz Pharma (us) Corp., this product is identified by NDC 59212-425.

Identification & Billing

NDC Package Code
59212-425-04
Package Description
4 TABLET in 1 BOTTLE, PLASTIC
Product Code
59212-425
11-Digit Billing Format
59212042504
RxNorm Crosswalk
  • RxCUI: 1046815 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG Oral Tablet
  • RxCUI: 1046815 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet
  • RxCUI: 1046978 - Donnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral Tablet
  • RxCUI: 1046978 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]
  • RxCUI: 1046978 - Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Donnatal
Non-Proprietary Name
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Substance Name
Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide
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)
Pharmacologic Class
Usage Information
This product contains several medications: belladonna alkaloids (made up of the drugs hyoscyamine, atropine, and scopolamine) and phenobarbital. Belladonna alkaloids help to reduce the symptoms of stomach and intestinal cramping. They work by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Belladonna alkaloids belong to a class of drugs known as anticholinergics/antispasmodics. Phenobarbital helps to reduce anxiety. It acts on the brain to produce a calming effect. Phenobarbital belongs to a class of drugs known as barbiturate sedatives.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Advanz Pharma (us) Corp.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
12-30-1980
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59212-425). Click a package code to view its specific billing and regulatory data.

59212-425-10
100 TABLET in 1 BOTTLE, PLASTIC
59212-425-11
1000 TABLET in 1 BOTTLE, PLASTIC

* 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 59212-425-04 identifies a specific commercial package of 4 tablet in 1 bottle, plastic of Donnatal, a human prescription drug labeled by Advanz Pharma (us) Corp.. This tablet is formulated for oral use and contains atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide 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 Advanz Pharma (us) Corp. on December 30, 1980. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product contains several medications: belladonna alkaloids (made up of the drugs hyoscyamine, atropine, and scopolamine) and phenobarbital. Belladonna alkaloids help to reduce the symptoms of stomach and intestinal cramping. They work by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Belladonna alkaloids belong to a class of drugs known as anticholinergics/antispasmodics. Phenobarbital helps to reduce anxiety. It acts on the brain to produce a calming effect. Phenobarbital belongs to a class of drugs known as barbiturate sedatives.

How is this Advanz Pharma (us) Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59212042504. 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)
59212-425-04
11-Digit CMS (5-4-2)
59212-0425-04

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