Clozaril (clozapine) NDC 69809-0127

NDC codes

FDA NDC Directory

Product NDC (as listed)69809-0127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69809-0127Add 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
69809-0127-5	69809012705	100 TABLET in 1 BOTTLE (69809-0127-5)Marketed from May 6, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Clozaril
Generic name (nonproprietary): clozapine
Active ingredients: Clozapine — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: HLS Therapeutics (USA), Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019758
Marketing start: May 6, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 69809-0127_14601465-eda2-4063-b606-cb6cfcaaca3dSPL ID 14601465-eda2-4063-b606-cb6cfcaaca3dSPL set ID 90876802-0e3a-44c9-9ff7-1754dfbe736aRxCUI 104775, 104776, 197535, 197536UNII J60AR2IKICUPC 0369809012752, 0369809012653
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

N469809012705 followed by a unit qualifier and the quantity

Package 69809-0127-05. 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 Jun 6, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

CLOZARIL 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, CLOZARIL 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 CLOZARIL is indicated for the treatment of severely ill patients with schizophrenia w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019758

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019758
Product	Strength	Form · route	Labeler	Product NDC
Clozarilclozapine	Clozapine 25 mg/1	TabletOral	HLS Therapeutics (USA), Inc.	69809-0126