Amlodipine And Valsartan Tablet
NDC Package 64380-216-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Amlodipine And Valsartan tablets is do not use in patients with known hypersensitivity to any component.Do not coadminister aliskiren with amlodipine and valsartan in patients with diabetes [see DRUG INTERACTIONS (7)]. This formulation utilizes a tablet delivery system. Marketed by Strides Pharma Science Limited, this product is identified by NDC 64380-216 and is authorized under FDA application ANDA090011.

Identification & Billing

NDC Package Code
64380-216-01
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
64380-216
11-Digit Billing Format
64380021601
RxNorm Crosswalk
  • 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

Proprietary Name
Amlodipine And Valsartan
Non-Proprietary Name
Amlodipine And Valsartan
Substance Name
Amlodipine; Valsartan
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not use in patients with known hypersensitivity to any component.Do not coadminister aliskiren with amlodipine and valsartan in patients with diabetes [see DRUG INTERACTIONS (7)].

Regulatory & Marketing

Labeler Name
Strides Pharma Science Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090011
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-24-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 (64380-216). Click a package code to view its specific billing and regulatory data.

64380-216-02
90 TABLET in 1 BOTTLE, PLASTIC

* 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 64380-216-01 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Amlodipine And Valsartan, a human prescription drug labeled by Strides Pharma Science Limited. This tablet is formulated for oral use and contains amlodipine; 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 Strides Pharma Science Limited on October 24, 2022. The current certification is valid through December 31, 2026.

How is this Strides Pharma Science Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64380021601. 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:

10-Digit Format (5-3-2)
64380-216-01
11-Digit CMS (5-4-2)
64380-0216-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.