Qlosi Solution
NDC Package 83661-018-60

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

Qlosi (pilocarpine hydrochloride) solution is qLOSI is indicated for the treatment of presbyopia in adults. This formulation utilizes a solution delivery system. Marketed by Orasis Pharmaceuticals, Inc., this product is identified by NDC 83661-018 and is authorized under FDA application NDA217836.

Identification & Billing

NDC Package Code
83661-018-60
Package Description
60 VIAL, SINGLE-USE in 1 BOX / .4 mL in 1 VIAL, SINGLE-USE
Product Code
83661-018
11-Digit Billing Format
83661001860
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Qlosi
Non-Proprietary Name
Pilocarpine Hydrochloride
Substance Name
Pilocarpine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
PILOCARPINE HYDROCHLORIDE 4 mg/mL
Pharmacologic Class
Usage Information
QLOSI is indicated for the treatment of presbyopia in adults.

Regulatory & Marketing

Labeler Name
Orasis Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217836
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-2024
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 (83661-018). Click a package code to view its specific billing and regulatory data.

83661-018-10
10 VIAL, SINGLE-USE in 1 BOX / .4 mL in 1 VIAL, SINGLE-USE
83661-018-20
20 VIAL, SINGLE-USE in 1 BOX / .4 mL in 1 VIAL, SINGLE-USE
83661-018-30
30 VIAL, SINGLE-USE in 1 BOX / .4 mL in 1 VIAL, SINGLE-USE

* 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 83661-018-60 identifies a specific commercial package of 60 vial, single-use in 1 box / .4 ml in 1 vial, single-use of Qlosi, a human prescription drug labeled by Orasis Pharmaceuticals, Inc.. This solution is formulated for ophthalmic use and contains pilocarpine 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 Orasis Pharmaceuticals, Inc. on October 15, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83661001860. 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)
83661-018-60
11-Digit CMS (5-4-2)
83661-0018-60

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