NDC 68382-431-06 Amlodipine And Atorvastatin

Amlodipine And Atorvastatin

NDC Package Code 68382-431-06

The NDC Code 68382-431-06 is assigned to a package of 30 tablet, film coated in 1 bottle 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.

Field Name Field Value
NDC Code 68382-431-06
Package Description 30 TABLET, FILM COATED in 1 BOTTLE
Proprietary Name Amlodipine And Atorvastatin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Amlodipine And Atorvastatin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 68382043106 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
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.
Active Ingredient(s)
  • AMLODIPINE BESYLATE 10 mg/1
  • ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1
Pharmacological Class(es)
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Dihydropyridines - [CS]
  • HMG-CoA Reductase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANDA207762 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 05-30-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 68382 - Zydus Pharmaceuticals (usa) Inc.
    • 68382-431 - Amlodipine And Atorvastatin
      • 68382-431-06 - 30 TABLET, FILM COATED in 1 BOTTLE

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 Amlodipine And Atorvastatin with product NDC 68382-431.

NDC Package CodePackage Description
68382-431-01100 TABLET, FILM COATED in 1 BOTTLE
68382-431-1690 TABLET, FILM COATED in 1 BOTTLE
68382-431-7710 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-431-30)

* Please review the disclaimer below.