Secuado Film, Extended Release
NDC Package 68968-0174-3

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

Secuado (asenapine) films is sECUADO is indicated for the treatment of adults with schizophrenia [see Clinical Studies (14)]. This formulation utilizes a film, extended release delivery system. Marketed by Noven Therapeutics, Llc, this product is identified by NDC 68968-0174 and is authorized under FDA application NDA212268.

Identification & Billing

NDC Package Code
68968-0174-3
Package Description
30 POUCH in 1 CARTON / 1 d in 1 POUCH
Product Code
68968-0174
11-Digit Billing Format
68968017403
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Secuado
Non-Proprietary Name
Asenapine
Substance Name
Asenapine
Dosage Form
Film, Extended Release - A drug delivery system in the form of a film that releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
ASENAPINE 7.6 mg/d
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
SECUADO is indicated for the treatment of adults with schizophrenia [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Noven Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA212268
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-12-2020
Listing Expiration
12-31-2026
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 (68968-0174). Click a package code to view its specific billing and regulatory data.

68968-0174-7
7 POUCH in 1 CARTON / 1 d in 1 POUCH

* 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 68968-0174-3 identifies a specific commercial package of 30 pouch in 1 carton / 1 d in 1 pouch of Secuado, a human prescription drug labeled by Noven Therapeutics, Llc. This film, extended release is formulated for transdermal use and contains asenapine 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 Noven Therapeutics, Llc on February 12, 2020. The current certification is valid through December 31, 2026.

How is this Noven Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68968017403. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:

10-Digit Format (5-4-1)
68968-0174-3
11-Digit CMS (5-4-2)
68968-0174-03

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