Clozapine NDC 0093-5416

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-5416Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-5416Add 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
0093-5416-01	00093541601	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01)Marketed from Apr 17, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 12.5 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090308
Marketing start: Apr 17, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 0093-5416_1b735bc2-6341-40af-8696-e61621d91ee8SPL ID 1b735bc2-6341-40af-8696-e61621d91ee8SPL set ID 6fccf4f7-2e30-4272-9800-225aaef20584RxCUI 476177, 476179, 721773, 996921, 1006801UNII 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

N400093541601 followed by a unit qualifier and the quantity

Package 00093-5416-01. 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 Jun 24, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Clozapine orally disintegrating tablets (Clozapine ODT) 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 ODT 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 Orally Disintegrating Tablet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090308

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

FDA NDC Directory listings under ANDA 090308
Product	Strength	Form · route	Labeler	Product NDC
Clozapine	Clozapine 150 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals USA, Inc.	0093-5376
Clozapine	Clozapine 200 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals USA, Inc.	0093-5377
Clozapine	Clozapine 25 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals USA, Inc.	0093-5417
Clozapine	Clozapine 100 mg/1	Tablet, Orally disintegratingOral	Teva Pharmaceuticals USA, Inc.	0093-5419