Oracea Capsule
NDC Package 0299-3822-07

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

Oracea (doxycycline) capsules is a medication used to treat a certain type of skin condition called rosacea. This formulation utilizes a capsule delivery system. Marketed by Galderma Laboratories, L.p., this product is identified by NDC 0299-3822 and is authorized under FDA application NDA050805.

Identification & Billing

NDC Package Code
0299-3822-07
Package Description
24 TRAY in 1 BOX / 4 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
Product Code
0299-3822
11-Digit Billing Format
00299382207
RxNorm Crosswalk
  • RxCUI: 901399 - doxycycline anhydrous 40 MG Delayed Release Oral Capsule
  • RxCUI: 901401 - Oracea 40 MG Delayed Release Oral Capsule
  • RxCUI: 901401 - doxycycline anhydrous 40 MG Delayed Release Oral Capsule [Oracea]

Clinical Specifications

Proprietary Name
Oracea
Non-Proprietary Name
Doxycycline
Substance Name
Doxycycline
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYCYCLINE 40 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a certain type of skin condition called rosacea. It helps to reduce the number of pimples and bumps on the face, but it may not decrease redness. It works by reducing skin inflammation caused by rosacea. Although doxycycline belongs to the class of antibiotics known as tetracyclines, this product does not work as an antibiotic because it does not stop the growth of bacteria. Therefore, do not use this product to treat any infection, including viral infections (such as the common cold, flu). Use this medication only as prescribed by your doctor.

Regulatory & Marketing

Labeler Name
Galderma Laboratories, L.p.
Product Type
Human Prescription Drug
FDA Application #
NDA050805
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-14-2010
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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 (0299-3822). Click a package code to view its specific billing and regulatory data.

0299-3822-02
12 TRAY in 1 BOX / 8 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
0299-3822-04
4 CAPSULE in 1 BLISTER PACK
0299-3822-05
8 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK
0299-3822-06
16 KIT in 1 BOX / 1 BLISTER PACK in 1 KIT / 4 CAPSULE in 1 BLISTER PACK
0299-3822-30
30 CAPSULE in 1 BOTTLE

* 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 0299-3822-07 identifies a specific commercial package of 24 tray in 1 box / 4 carton in 1 tray / 1 blister pack in 1 carton / 2 capsule in 1 blister pack of Oracea, a human prescription drug labeled by Galderma Laboratories, L.p.. This capsule is formulated for oral use and contains doxycycline 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 May 14, 2010. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain type of skin condition called rosacea. It helps to reduce the number of pimples and bumps on the face, but it may not decrease redness. It works by reducing skin inflammation caused by rosacea. Although doxycycline belongs to the class of antibiotics known as tetracyclines, this product does not work as an antibiotic because it does not stop the growth of bacteria. Therefore, do not use this product to treat any infection, including viral infections (such as the common cold, flu). Use this medication only as prescribed by your doctor.

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: 00299382207. 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 (4-4-2)
0299-3822-07
11-Digit CMS (5-4-2)
00299-3822-07

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