NDC Package 48943-0010-4 Isotretinoin

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

Package Information
Other Packages
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:

48943-0010-4

Package Description:

10 kg in 1 DRUM

Product Code:

48943-0010

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:

48943001004

Product Type:

Bulk Ingredient

Labeler Name:

Chongqing Huapont Pharmaceutical Co Limited

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Active Ingredient(s):

ISOTRETINOIN 1 kg/kg

Sample Package:

N/A

Marketing Category:

BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.

Start Marketing Date:

01-01-2003

Listing Expiration Date:

12-31-2024

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

48943 - Chongqing Huapont Pharmaceutical Co Limited
- 48943-0010 -
  - 48943-0010-4 - 10 kg in 1 DRUM

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 Code	Package Description
48943-0010-0	25 kg in 1 DRUM
48943-0010-1	1 kg in 1 DRUM
48943-0010-2	3 kg in 1 DRUM
48943-0010-3	5 kg in 1 DRUM

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 48943-0010-4?

The NDC Packaged Code 48943-0010-4 is assigned to an UNFINISHED drug package of 10 kg in 1 drum of Isotretinoin, a bulk ingredient labeled by Chongqing Huapont Pharmaceutical Co Limited. The product's dosage form is powder and is administered via form.

Is NDC 48943-0010 included in the NDC Directory?

Yes, Isotretinoin is an UNFINISHED PRODUCT with code 48943-0010 that is active and included in the NDC Directory. The product was first marketed by Chongqing Huapont Pharmaceutical Co Limited on January 01, 2003 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 48943-0010-4?

The 11-digit format is 48943001004. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	48943-0010-4	5-4-2	48943-0010-04

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