Epiduo Forte Gel
NDC Package 0299-5906-45
Package Information
Epiduo Forte (adapalene and benzoyl peroxide) gel is a medication used on the skin to treat acne. This formulation utilizes a gel delivery system. Marketed by Galderma Laboratories, L.p., this product is identified by NDC 0299-5906 and is authorized under FDA application NDA207917.
Identification & Billing
- RxCUI: 1663745 - adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel
- RxCUI: 1663745 - adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel
- RxCUI: 1663747 - Epiduo Forte 0.3 % / 2.5 % Topical Gel
- RxCUI: 1663747 - adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0299 - Galderma Laboratories, L.p.
- 0299-5906 - Epiduo Forte
- 0299-5906-45 - 1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP
- 0299-5906 - Epiduo Forte
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 (0299-5906). Click a package code to view its specific billing and regulatory data.
* 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 0299-5906-45 identifies a specific commercial package of 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump of Epiduo Forte, a human prescription drug labeled by Galderma Laboratories, L.p.. This gel is formulated for topical use and contains adapalene; benzoyl peroxide 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 Galderma Laboratories, L.p. on July 01, 2015. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This medication is used on the skin to treat acne. This medication is a combination of adapalene (a retinoid) and benzoyl peroxide (an antibiotic and skin-peeling agent). This product may decrease the number and severity of acne pimples and promote quick healing of pimples that do appear. Adapalene works by affecting the growth of cells and decreasing swelling and inflammation. Benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off..
How is this Galderma Laboratories, L.p. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00299590645. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 total billable units per package. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
