Donnatal
NDC 66213-422

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 66213-422?
  5. Donnatal Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Donnatal is a UNAPPROVED DRUG OTHER-approved product labeled by Pbm Pharmaceuticals Inc.. This product contains several medications: belladonna alkaloids (made up of the drugs hyoscyamine, atropine, and scopolamine) and phenobarbital. It is supplied as a green product. This product entry covers the primary NDC 66213-422 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
66213-422
Proprietary Name:
Donnatal
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Pbm Pharmaceuticals Inc.
Labeler Code:
66213
Product Label ID:
8d395651-e406-4448-98a7-fc6afc61282d
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
07-01-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GREEN (C48329)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 66213-422?

The NDC code 66213-422 is assigned by the FDA to the product Donnatal. This pharmaceutical product is labeled by Pbm Pharmaceuticals Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 66213-422-04, 66213-422-16. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".