Seysara Tablet, Coated
NDC Package 16110-247-00

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

Seysara (sarecycline hydrochloride) tablets is sEYSARA™ (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.Limitations of UseEfficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. This formulation utilizes a tablet, coated delivery system. Marketed by Almirall, Llc, this product is identified by NDC 16110-247 and is authorized under FDA application NDA209521.

Identification & Billing

NDC Package Code
16110-247-00
Package Description
192000 TABLET, COATED in 1 BAG
Product Code
16110-247
11-Digit Billing Format
16110024700
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Seysara
Non-Proprietary Name
Sarecycline Hydrochloride
Substance Name
Sarecycline Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
SEYSARA™ (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.Limitations of UseEfficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies (14)].To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions (5.6)].

Regulatory & Marketing

Labeler Name
Almirall, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA209521
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-04-2019
Listing Expiration
12-31-2026
Exclude Flag
N
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 (16110-247). Click a package code to view its specific billing and regulatory data.

16110-247-30
30 TABLET, COATED 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 16110-247-00 identifies a specific commercial package of 192000 tablet, coated in 1 bag of Seysara, a human prescription drug labeled by Almirall, Llc. This tablet, coated is formulated for oral use and contains sarecycline hydrochloride 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 Almirall, Llc on January 04, 2019. The current certification is valid through December 31, 2026.

How is this Almirall, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16110024700. 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 (5-3-2)
16110-247-00
11-Digit CMS (5-4-2)
16110-0247-00

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