Isotretinoin Powder
NDC Package 48943-0010-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Isotretinoin powders is a medication 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). This formulation utilizes a powder delivery system. Marketed by Chongqing Huapont Pharmaceutical Co Limited, this product is identified by NDC 48943-0010.

Identification & Billing

NDC Package Code
48943-0010-2
Package Description
3 kg in 1 DRUM
Product Code
48943-0010
11-Digit Billing Format
48943001002

Clinical Specifications

Proprietary Name
Isotretinoin
Non-Proprietary Name
Isotretinoin
Substance Name
Isotretinoin
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
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.

Regulatory & Marketing

Labeler Name
Chongqing Huapont Pharmaceutical Co Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2003
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (48943-0010). Click a package code to view its specific billing and regulatory data.

48943-0010-0
25 kg in 1 DRUM
48943-0010-1
1 kg in 1 DRUM
48943-0010-3
5 kg in 1 DRUM
48943-0010-4
10 kg in 1 DRUM

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48943-0010-2 identifies a specific commercial package of 3 kg in 1 drum of Isotretinoin (UNFINISHED drug), a bulk ingredient labeled by Chongqing Huapont Pharmaceutical Co Limited. This powder is formulated for use and contains isotretinoin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Chongqing Huapont Pharmaceutical Co Limited on January 01, 2003. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Chongqing Huapont Pharmaceutical Co Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48943001002. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
48943-0010-2
11-Digit CMS (5-4-2)
48943-0010-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.