NDC Package 68382-427-77 Amlodipine And Atorvastatin

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

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:
68382-427-77
Package Description:
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-427-30)
Product Code:
Proprietary Name:
Amlodipine And Atorvastatin
Non-Proprietary Name:
Amlodipine And Atorvastatin
Substance Name:
Amlodipine Besylate; Atorvastatin Calcium Trihydrate
Usage Information:
  Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels   Pregnancy [see Use in Specific Populations (8.1)]  Lactation [see Use in Specific Populations (8.2)]
11-Digit NDC Billing Format:
68382042777
NDC to RxNorm Crosswalk:
  • RxCUI: 404011 - amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet
  • RxCUI: 404011 - amlodipine 5 MG / atorvastatin 80 MG Oral Tablet
  • RxCUI: 404011 - amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet
  • RxCUI: 404013 - amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet
  • RxCUI: 404013 - amlodipine 10 MG / atorvastatin 80 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals (usa) Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA207762
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-30-2019
    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
    68382-427-01100 TABLET, FILM COATED in 1 BOTTLE
    68382-427-0630 TABLET, FILM COATED in 1 BOTTLE
    68382-427-1690 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68382-427-77?

    The NDC Packaged Code 68382-427-77 is assigned to a package of 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack (68382-427-30) of Amlodipine And Atorvastatin, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 68382-427 included in the NDC Directory?

    Yes, Amlodipine And Atorvastatin with product code 68382-427 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals (usa) Inc. on May 30, 2019 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 68382-427-77?

    The 11-digit format is 68382042777. 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
    5-3-268382-427-775-4-268382-0427-77