Versacloz (clozapine) NDC 52817-601

NDC codes

FDA NDC Directory

Product NDC (as listed)52817-601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52817-0601Add 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
52817-601-38	52817060138	1 BOTTLE in 1 BOX (52817-601-38) / 100 mL in 1 BOTTLEMarketed from Jun 15, 2018

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): Versacloz
Generic name (nonproprietary): clozapine
Active ingredients: Clozapine — 50 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: TruPharma LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203479
Marketing start: Jun 15, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 52817-601_5ad93201-28d4-44d3-e063-6394a90ab9daSPL ID 5ad93201-28d4-44d3-e063-6394a90ab9daSPL set ID 2592c9a8-fd74-4e0d-a895-b07b014cf355RxCUI 1369825, 1369831UNII J60AR2IKICUPC 0352817601384
Pharmacologic class: Atypical Antipsychotic

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N452817060138 followed by a unit qualifier and the quantity

Package 52817-0601-38. 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 Sep 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

VERSACLOZ is an atypical antipsychotic indicated for: Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, VERSACLOZ should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1). Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2). 1.1 Treatment-Resistant Schizophrenia VERSACLOZ is indicated for the treatment of severely ill patients with schizophrenia who f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)