Prescription drug · ANDA
Clozapine NDC 59651-264
Clozapine 200 mg/1 · Tablet, Orally disintegrating · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-264-01 | 59651026401 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-264-01)Marketed from Dec 12, 2024 | |
| 59651-264-48 | 59651026448 | 8 BLISTER PACK in 1 CARTON (59651-264-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 12, 2024 |
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 — 200 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212923
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-264_5fe42ada-7ea2-4b77-bad5-93e1b1fb765dSPL ID 5fe42ada-7ea2-4b77-bad5-93e1b1fb765dSPL set ID caf2d4a6-2a23-4992-a807-560c4204afc4RxCUI 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
N459651026401followed by a unit qualifier and the quantityPackage 59651-0264-01. 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 . 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 212923
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 150 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-263 |
| Clozapine | Clozapine 12.5 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-260 |
| Clozapine | Clozapine 25 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-261 |
| Clozapine | Clozapine 100 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-262 |