Vraylar Capsule, Gelatin Coated
NDC Package 61874-145-07

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

Vraylar (cariprazine) capsules is cariprazine is used to treat certain mental/mood disorders (such as bipolar disorder, bipolar depression, schizophrenia). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Allergan, Inc., this product is identified by NDC 61874-145 and is authorized under FDA application NDA204370.

Identification & Billing

NDC Package Code
61874-145-07
Package Description
7 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Product Code
61874-145
11-Digit Billing Format
61874014507
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vraylar
Non-Proprietary Name
Cariprazine
Substance Name
Cariprazine
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARIPRAZINE 4.5 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Cariprazine is used to treat certain mental/mood disorders (such as bipolar disorder, bipolar depression, schizophrenia). Cariprazine belongs to a class of drugs known as atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. This medication can decrease hallucinations, help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.

Regulatory & Marketing

Labeler Name
Allergan, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204370
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-17-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (61874-145). Click a package code to view its specific billing and regulatory data.

61874-145-30
30 CAPSULE, GELATIN COATED in 1 BOTTLE
61874-145-90
90 CAPSULE, GELATIN 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 61874-145-07 identifies a specific commercial package of 7 capsule, gelatin coated in 1 blister pack of Vraylar, a human prescription drug labeled by Allergan, Inc.. This capsule, gelatin coated is formulated for oral use and contains cariprazine 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 Allergan, Inc. on September 17, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cariprazine is used to treat certain mental/mood disorders (such as bipolar disorder, bipolar depression, schizophrenia). Cariprazine belongs to a class of drugs known as atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. This medication can decrease hallucinations, help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.

How is this Allergan, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61874014507. 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)
61874-145-07
11-Digit CMS (5-4-2)
61874-0145-07

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