Amlodipine And Valsartan Tablet
NDC Package 33342-280-10
Package Information
Amlodipine And Valsartan tablets is do not use in patients with known hypersensitivity to any component. This formulation utilizes a tablet delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-280 and is authorized under FDA application ANDA207292.
Identification & Billing
- RxCUI: 722126 - amLODIPine 10 MG / valsartan 160 MG Oral Tablet
- RxCUI: 722126 - amlodipine 10 MG / valsartan 160 MG Oral Tablet
- RxCUI: 722126 - amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral Tablet
- RxCUI: 722131 - amLODIPine 10 MG / valsartan 320 MG Oral Tablet
- RxCUI: 722131 - amlodipine 10 MG / valsartan 320 MG Oral Tablet
Clinical Specifications
- Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
- Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
- Calcium Channel Antagonists - [MoA] (Mechanism of Action)
- Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
- Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
- Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
- Dihydropyridines - [CS]
Regulatory & Marketing
Hierarchy Structure
- 33342 - Macleods Pharmaceuticals Limited
- 33342-280 - Amlodipine And Valsartan
- 33342-280-10 - 90 TABLET in 1 BOTTLE
- 33342-280 - Amlodipine And Valsartan
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 (33342-280). 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 33342-280-10 identifies a specific commercial package of 90 tablet in 1 bottle of Amlodipine And Valsartan, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet is formulated for oral use and contains amlodipine besylate; valsartan as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Macleods Pharmaceuticals Limited on October 16, 2024. The current certification is valid through December 31, 2026.
How is this Macleods Pharmaceuticals Limited product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342028010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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.
