Amlodipine Besylate
NDC Package 12634-562-71
Package Information
Amlodipine Besylate is amlodipine is used with or without other medications to treat high blood pressure. Marketed by Apotheca Inc., this product is identified by NDC 12634-562 and is authorized under FDA application ANDA203245.
Identification & Billing
- RxCUI: 197361 - amLODIPine besylate 5 MG Oral Tablet
- RxCUI: 197361 - amlodipine 5 MG Oral Tablet
- RxCUI: 197361 - amlodipine (as amlodipine besylate) 5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 12634 - Apotheca Inc.
- 12634-562 - Amlodipine Besylate
- 12634-562-71 - 30 TABLET in 1 BOTTLE
- 12634-562 - Amlodipine Besylate
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 (12634-562). 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 12634-562-71 identifies a specific commercial package of 30 tablet in 1 bottle of Amlodipine Besylate, 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 March 03, 2014. The current certification is valid through December 31, 2022.
What are the primary indications for this medication?
Amlodipine is used with or without other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. Amlodipine is also used to prevent certain types of chest pain (angina). It may help to increase your ability to exercise and decrease the frequency of angina attacks. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor.
How is this Apotheca Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634056271. 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.
