What is NDC 59310-610?

59310-610 is the product NDC for Cinqair (reslizumab), Reslizumab 10 mg/mL injection, solution, concentrate, listed with the FDA by Teva Respiratory, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Respiratory, LLC, NDC labeler code 59310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cinqair?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cinqair NDC 59310-610 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59310-610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59310-0610Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59310-610-31	59310061031	1 VIAL, SINGLE-USE in 1 CARTON (59310-610-31) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Apr 18, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cinqair
Generic name (nonproprietary): reslizumab
Active ingredients: Reslizumab — 10 mg/mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Teva Respiratory, LLCNDC labeler code 59310
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761033
Marketing start: Apr 18, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Interleukin-5 Antagonists (Mechanism)
Identifiers: Product ID 59310-610_a509df2c-67b6-40c3-8b6d-f9de54b62c8aSPL ID a509df2c-67b6-40c3-8b6d-f9de54b62c8aSPL set ID 053b9158-2a5b-48b9-bf47-5fa78a35ec33RxCUI 1746893, 1746898UNII 35A26E427H
Pharmacologic class: Interleukin-5 Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N459310061031 followed by a unit qualifier and the quantity

Package 59310-0610-31. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 29, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

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 )] . CINQAIR is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype ( 1 ). Limitations of Use : CINQAIR is not indicated for: treatment of other eosinophilic condition…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59310-610

What is NDC 59310-610?: 59310-610 is the product NDC for Cinqair (reslizumab), Reslizumab 10 mg/mL injection, solution, concentrate, listed with the FDA by Teva Respiratory, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cinqair (Reslizumab).
What is the active ingredient?: Reslizumab.
Who is the labeler?: Teva Respiratory, LLC, NDC labeler code 59310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cinqair?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Cinqair (Reslizumab) NDC 59310-610