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  5. NDC Package Code: 16110-246-30 Seysara

NDC Package 16110-246-30 Seysara

Sarecycline Hydrochloride Tablet, Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
16110-246-30
Package Description:
30 TABLET, COATED in 1 BOTTLE
Product Code:
16110-246
Proprietary Name:
Seysara
Non-Proprietary Name:
Sarecycline Hydrochloride
Substance Name:
Sarecycline Hydrochloride
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)].
11-Digit NDC Billing Format:
16110024630
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2059023 - sarecycline 100 MG Oral Tablet
  • RxCUI: 2059023 - sarecycline 100 MG (as sarecycline HCl 107.5 MG) Oral Tablet
  • RxCUI: 2059029 - Seysara 100 MG Oral Tablet
  • RxCUI: 2059029 - sarecycline 100 MG Oral Tablet [Seysara]
  • RxCUI: 2059029 - Seysara 100 MG (as sarecycline HCl 107.5 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Almirall, Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SARECYCLINE HYDROCHLORIDE 100 mg/1
    • Pharmacologic Class(es):
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • Tetracycline-class Drug - [EPC] (Established Pharmacologic Class)
  • Tetracyclines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA209521
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-04-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Frequently Asked Questions

    What is NDC 16110-246-30?

    The NDC Packaged Code 16110-246-30 is assigned to a package of 30 tablet, coated in 1 bottle of Seysara, a human prescription drug labeled by Almirall, Llc. The product's dosage form is tablet, coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 16110-246 included in the NDC Directory?

    Yes, Seysara with product code 16110-246 is active and included in the NDC Directory. The product was first marketed by Almirall, Llc on January 04, 2019 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 NDC billing unit for package 16110-246-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 16110-246-30?

    The 11-digit format is 16110024630. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-216110-246-305-4-216110-0246-30