NDC Package 59212-422-04 Donnatal

Phenobarbital,Hyoscyamine Sulfate,Atropine Sulfate,Scopolamine Hydrobromide Elixir Oral - View Billable Units, 11-Digit Format, RxNorm

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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:

59212-422-04

Package Description:

118 mL in 1 BOTTLE

Product Code:

59212-422

Proprietary Name:

Donnatal

Non-Proprietary Name:

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

Substance Name:

Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide

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.

11-Digit NDC Billing Format:

59212042204

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

118 ML

NDC to RxNorm Crosswalk:

RxCUI: 1046787 - PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral Solution

RxCUI: 1046787 - atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution

RxCUI: 1046787 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral Solution

RxCUI: 1046924 - Donnatal 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution

RxCUI: 1046924 - atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Donnatal]

Product Type:

Human Prescription Drug

Labeler Name:

Concordia Pharmaceuticals Inc.

Dosage Form:

Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

ATROPINE SULFATE .0194 mg/5mL

HYOSCYAMINE SULFATE .1037 mg/5mL

PHENOBARBITAL 16.2 mg/5mL

SCOPOLAMINE HYDROBROMIDE .0065 mg/5mL

Pharmacologic Class(es):

Anticholinergic - [EPC] (Established Pharmacologic Class)

Cholinergic Antagonists - [MoA] (Mechanism of Action)

Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)

Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)

DEA Schedule:

Schedule IV (CIV) Substances

Sample Package:

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 Date:

12-31-2024

Exclude Flag:

Code Structure:

59212 - Concordia Pharmaceuticals Inc.
- 59212-422 - Donnatal
  - 59212-422-04 - 118 mL 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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
59212-422-10	10 mL in 1 BOTTLE
59212-422-16	473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 59212-422-04?

The NDC Packaged Code 59212-422-04 is assigned to a package of 118 ml in 1 bottle of Donnatal, a human prescription drug labeled by Concordia Pharmaceuticals Inc.. The product's dosage form is elixir and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package.

Is NDC 59212-422 included in the NDC Directory?

Yes, Donnatal with product code 59212-422 is active and included in the NDC Directory. The product was first marketed by Concordia Pharmaceuticals Inc. on December 30, 1980 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 59212-422-04?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 118.

What is the 11-digit format for NDC 59212-422-04?

The 11-digit format is 59212042204. 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	59212-422-04	5-4-2	59212-0422-04

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