Cinqair Injection, Solution, Concentrate
NDC Package 59310-610-31

11-digit billing NDC: 59310061031 · Billing unit: ML · 10 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Cinqair (reslizumab) injection is cINQAIR® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)].Limitation of Use:CINQAIR is not indicated for treatment of other eosinophilic conditions.CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions (5.2)]. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Teva Respiratory, Llc, this product is identified by NDC 59310-610 and is authorized under FDA application BLA761033.

Identification & Billing

NDC Package Code
59310-610-31
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE
Product Code
59310-610
11-Digit Billing Format
59310061031
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cinqair
Non-Proprietary Name
Reslizumab
Substance Name
Reslizumab
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
RESLIZUMAB 10 mg/mL
Pharmacologic Class
Usage Information
CINQAIR® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)].Limitation of Use:CINQAIR is not indicated for treatment of other eosinophilic conditions.CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions (5.2)].

Regulatory & Marketing

Labeler Name
Teva Respiratory, Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761033
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-18-2016
Listing Expiration
12-31-2027
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2786
Source: ASP
Injection, reslizumab, 1mg
HCPCS Dosage 1 MG
Units / Pkg 100

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (59310-610). Click a package code to view its specific billing and regulatory data.

59310-610-33
1 VIAL, SINGLE-USE in 1 CARTON / 10 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 59310-610-31 identifies a specific commercial package of 1 vial, single-use in 1 carton / 10 ml in 1 vial, single-use of Cinqair, a human prescription drug labeled by Teva Respiratory, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. This injection, solution, concentrate is formulated for intravenous use and contains reslizumab 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 Teva Respiratory, Llc on April 18, 2016. The current certification is valid through December 31, 2027.

How is this Teva Respiratory, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59310061031. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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 (5-3-2)
59310-610-31
11-Digit CMS (5-4-2)
59310-0610-31

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