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  4. NDC Product Code: 66213-421 Donnatal Extentabs

NDC 66213-421 Donnatal Extentabs

View Dosage, Usage, Ingredients, Routes, UNII

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.
NDC Product Code:
66213-421
Proprietary Name:
Donnatal Extentabs
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Pbm Pharmaceuticals, Inc
Labeler Code:
66213
Product Label ID:
2064014b-6f8e-4232-88c2-d1870042abc7
Start Marketing Date: [9]
05-07-2008
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

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

Product Packages

NDC Code 66213-421-10

Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 66213-421-50

Package Description: 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 66213-421?

The NDC code 66213-421 is assigned by the FDA to the product Donnatal Extentabs which is product labeled by Pbm Pharmaceuticals, Inc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 66213-421-10 100 tablet, film coated, extended release in 1 bottle, plastic , 66213-421-50 500 tablet, film coated, extended release in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Donnatal Extentabs?

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 Donnatal Extentabs UNII Codes?

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

Which are Donnatal Extentabs Inactive Ingredients 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 Donnatal Extentabs?

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 disclaimer below.

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 disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".