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  5. NDC Package Code: 64566-0004-1 Isotretinoin

NDC Package 64566-0004-1 Isotretinoin

Capsule - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
64566-0004-1
Package Description:
1 BAG in 1 CARTON / 18000 CAPSULE in 1 BAG
Product Code:
64566-0004
Non-Proprietary Name:
Isotretinoin
Substance Name:
Isotretinoin
Usage Information:
This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.
11-Digit NDC Billing Format:
64566000401
Product Type:
Drug For Further Processing
Labeler Name:
Catalent France Beinheim S.a.
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s):
ISOTRETINOIN 40 mg/1
Sample Package:
N/A
Marketing Category:
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date:
11-11-2002
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Unfinished Product:
Yes
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.

Frequently Asked Questions

What is NDC 64566-0004-1?

The NDC Packaged Code 64566-0004-1 is assigned to an UNFINISHED drug package of 1 bag in 1 carton / 18000 capsule in 1 bag of Isotretinoin, drug for further processing labeled by Catalent France Beinheim S.a.. The product's dosage form is capsule and is administered via form.

Is NDC 64566-0004 included in the NDC Directory?

Yes, Isotretinoin is an UNFINISHED PRODUCT with code 64566-0004 that is active and included in the NDC Directory. The product was first marketed by Catalent France Beinheim S.a. on November 11, 2002 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 64566-0004-1?

The 11-digit format is 64566000401. 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 5-4-1 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
5-4-164566-0004-15-4-264566-0004-01