Donnatal Extentabs
NDC 66213-421

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 66213-421?
  5. Donnatal Extentabs Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

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

Donnatal Extentabs is a UNAPPROVED DRUG OTHER-approved product labeled by Pbm Pharmaceuticals, Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a green product. This product entry covers the primary NDC 66213-421 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
66213-421
Proprietary Name:
Donnatal Extentabs
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:
2064014b-6f8e-4232-88c2-d1870042abc7
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]
05-07-2008
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GREEN (C48329 - FILM COATED)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
421
Score:
1

Code Structure Chart

Product Details

What is NDC 66213-421?

The NDC code 66213-421 is assigned by the FDA to the product Donnatal Extentabs. 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: 66213-421-10, 66213-421-50. 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?

Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the following indications as “possibly” effective:For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.May also be useful as adjunctive therapy in the treatment of duodenal ulcer.  IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

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: 1046997 - atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / PHENobarbital 48.6 MG / scopolamine HBr 0.0195 MG Extended Release Oral Tablet
  • RxCUI: 1046997 - atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / phenobarbital 48.6 MG / scopolamine hydrobromide 0.0195 MG Extended Release Oral Tablet
  • RxCUI: 1046999 - Donnatal Extentabs 0.0582 MG / 0.311 MG / 48.6 MG / 0.0195 MG Extended Release Oral Tablet
  • RxCUI: 1046999 - atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / phenobarbital 48.6 MG / scopolamine hydrobromide 0.0195 MG Extended Release Oral Tablet [Donnatal]
  • RxCUI: 1046999 - Donnatal (atropine sulfate 0.0582 MG / hyoscyamine sulfate 0.311 MG / phenobarbital 48.6 MG / scopolamine hydrobromide 0.0195 MG) Extended Release Oral Tablet

* Please review the full disclaimer at the bottom of this page.

Patient Education

Belladonna Alkaloid Combinations and Phenobarbital


Belladonna alkaloid combinations and phenobarbital are used to relieve cramping pains in conditions such as irritable bowel syndrome and spastic colon. They also are used with other medicine to treat ulcers. These medicines decrease the motion of the stomach and intestines and the secretion of stomach fluids, including acid. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

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".