Amlodipine And Valsartan Tablet, Film Coated
NDC Package 0378-1721-93

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 tablets in patients with diabetes [see Drug Interactions (7)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-1721 and is authorized under FDA application ANDA090483.

Identification & Billing

NDC Package Code
0378-1721-93
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0378-1721
11-Digit Billing Format
00378172193
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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 Besylate; Valsartan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
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 tablets in patients with diabetes [see Drug Interactions (7)].

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090483
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-30-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-1721-93 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Amlodipine And Valsartan, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet, film coated 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 Mylan Pharmaceuticals Inc. on March 30, 2015. The current certification is valid through December 31, 2026.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378172193. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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:

10-Digit Format (4-4-2)
0378-1721-93
11-Digit CMS (5-4-2)
00378-1721-93

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