Prescription drug · ANDA
Clozapine NDC 0378-0860
Clozapine 100 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0860-01 | 00378086001 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-01)Marketed from Jul 8, 1999 | |
| 0378-0860-05 | 00378086005 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0860-05)Marketed from Feb 5, 2001 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075417
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-0860_a8cef9ad-4bf9-4289-9473-400c8f1a95acSPL ID a8cef9ad-4bf9-4289-9473-400c8f1a95acSPL set ID 883b5d43-0339-7dc1-f775-93791fb9b978RxCUI 197535, 197536, 309374, 429212UNII 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
N400378086001followed by a unit qualifier and the quantityPackage 00378-0860-01. 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 tablets are 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075417
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 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0825 |
| Clozapine | Clozapine 50 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0972 |
| Clozapine | Clozapine 25 mg/1 | TabletOral | Safecor Health LLC | 48433-023 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0973 |
| Clozapine | Clozapine 100 mg/1 | TabletOral | Safecor Health LLC | 48433-024 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | Safecor Health LLC | 48433-025 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-749 |
| Clozapine | Clozapine 25 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-921 |
| Clozapine | Clozapine 100 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-922 |