Donnatal Extentabs
NDC Package 66213-421-50
Package Information
Donnatal Extentabs is 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. Marketed by Pbm Pharmaceuticals, Inc, this product is identified by NDC 66213-421.
Identification & Billing
- 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
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 66213 - Pbm Pharmaceuticals, Inc
- 66213-421 - Donnatal Extentabs
- 66213-421-50 - 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
- 66213-421 - Donnatal Extentabs
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 (66213-421). Click a package code to view its specific billing and regulatory data.
* 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 66213-421-50 identifies a specific commercial package of 500 tablet, film coated, extended release in 1 bottle, plastic of Donnatal Extentabs, labeled by Pbm Pharmaceuticals, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Pbm Pharmaceuticals, Inc on May 07, 2008. The current certification is valid through December 31, 2018.
How is this Pbm Pharmaceuticals, Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 66213042150. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
