Prescription drug · ANDA
Clozapine NDC 48433-022
Clozapine 100 mg/1 · Tablet, Orally disintegrating · Oral · Safecor Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-022-04 | 48433002204 | 40 BLISTER PACK in 1 CARTON (48433-022-04) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (48433-022-01)Marketed from Mar 5, 2026 |
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, Orally disintegrating
- Route
- Oral
- Labeler
- Safecor Health, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201824
- Marketing start
- Listing expires
- Identifiers
- Product ID 48433-022_4cedfa23-a6bd-ddf7-e063-6294a90aa994SPL ID 4cedfa23-a6bd-ddf7-e063-6294a90aa994SPL set ID 09231d80-6343-4a34-bd5b-100c547fd3c9RxCUI 476177UNII 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
N448433002204followed by a unit qualifier and the quantityPackage 48433-0022-04. 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 . 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.
Other NDCs under ANDA 201824
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clozapine | Clozapine 25 mg/1 | Tablet, Orally disintegratingOral | Mylan Pharmaceuticals Inc. | 0378-3813 |
| Clozapine | Clozapine 100 mg/1 | Tablet, Orally disintegratingOral | Mylan Institutional Inc. | 51079-288 |
| Clozapine | Clozapine 100 mg/1 | Tablet, Orally disintegratingOral | Mylan Pharmaceuticals Inc. | 0378-3815 |
| Clozapine | Clozapine 150 mg/1 | Tablet, Orally disintegratingOral | Mylan Pharmaceuticals Inc. | 0378-3816 |
| Clozapine | Clozapine 200 mg/1 | Tablet, Orally disintegratingOral | Mylan Pharmaceuticals Inc. | 0378-3817 |