Diethylpropion Hydrochloride Er
NDC Package 12634-691-91
Package Information
Diethylpropion Hydrochloride Er is diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Marketed by Apotheca Inc, this product is identified by NDC 12634-691 and is authorized under FDA application ANDA011722.
Identification & Billing
- RxCUI: 978668 - diethylpropion HCl 75 MG 24HR Extended Release Oral Tablet
- RxCUI: 978668 - 24 HR diethylpropion hydrochloride 75 MG Extended Release Oral Tablet
- RxCUI: 978668 - diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 12634 - Apotheca Inc
- 12634-691 - Diethylpropion Hydrochloride Er
- 12634-691-91 - 1 TABLET in 1 BLISTER PACK
- 12634-691 - Diethylpropion Hydrochloride Er
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 (12634-691). 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 12634-691-91 identifies a specific commercial package of 1 tablet in 1 blister pack of Diethylpropion Hydrochloride Er, labeled by Apotheca Inc. 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 Apotheca Inc on October 23, 2008. The current certification is valid through January 23, 2017.
How is this Apotheca Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634069191. 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.
