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  5. NDC Package Code: 64380-216-01 Amlodipine And Valsartan

NDC Package 64380-216-01 Amlodipine And Valsartan

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
64380-216-01
Package Description:
30 TABLET in 1 BOTTLE, PLASTIC
Product Code:
64380-216
Proprietary Name:
Amlodipine And Valsartan
Non-Proprietary Name:
Amlodipine And Valsartan
Substance Name:
Amlodipine; Valsartan
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)].
11-Digit NDC Billing Format:
64380021601
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Strides Pharma Science Limited
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMLODIPINE 5 mg/1
  • VALSARTAN 320 mg/1
    • Pharmacologic Class(es):
  • 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]
    • Sample Package:
    No
    FDA Application Number:
    ANDA090011
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-24-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    64380-216-0290 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 64380-216-01?

    The NDC Packaged Code 64380-216-01 is assigned to a package of 30 tablet in 1 bottle, plastic of Amlodipine And Valsartan, a human prescription drug labeled by Strides Pharma Science Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 64380-216 included in the NDC Directory?

    Yes, Amlodipine And Valsartan with product code 64380-216 is active and included in the NDC Directory. The product was first marketed by Strides Pharma Science Limited on October 24, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 64380-216-01?

    The 11-digit format is 64380021601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-264380-216-015-4-264380-0216-01