Clozapine NDC 16729-142

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-142Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0142Add 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
16729-142-01	16729014201	100 TABLET in 1 BOTTLE (16729-142-01)Marketed from Apr 10, 2017
16729-142-16	16729014216	500 TABLET in 1 BOTTLE (16729-142-16)Marketed from May 17, 2017

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): Clozapine
Generic name (nonproprietary): clozapine
Active ingredients: Clozapine — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202873
Marketing start: Apr 10, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 16729-142_40aa4dd3-36ca-1132-e063-6394a90a268dSPL ID 40aa4dd3-36ca-1132-e063-6394a90a268dSPL set ID 25c0c6d5-f7b0-48e4-e054-00144ff8d46cRxCUI 197535, 197536UNII J60AR2IKIC
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

N416729014201 followed by a unit qualifier and the quantity

Package 16729-0142-01. 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 Oct 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Clozapine tablets 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, clozapine tablets 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 Clozapine tablets are indicated for the treatment of severely ill patients…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202873

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

FDA NDC Directory listings under ANDA 202873
Product	Strength	Form · route	Labeler	Product NDC
Clozapine	Clozapine 25 mg/1	TabletOral	Accord Healthcare Inc.	16729-141