Prescription drug · ANDA
Clozapine NDC 55154-3568
Clozapine 100 mg/1 · Tablet · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-3568-0 | 55154356800 | 10 BLISTER PACK in 1 BAG (55154-3568-0) / 1 TABLET in 1 BLISTER PACKMarketed from Nov 29, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206433
- Marketing start
- Listing expires
- Identifiers
- Product ID 55154-3568_d8831827-913d-4672-922a-629f5d93942eSPL ID d8831827-913d-4672-922a-629f5d93942eSPL set ID 7c748f8a-73ce-4bd3-aa30-9c66657f06ecRxCUI 197535UNII J60AR2IKICUPC 0055154356800
- 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
N455154356800followed by a unit qualifier and the quantityPackage 55154-3568-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 206433
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 100 mg/1 | TabletOral | NorthStar Rx LLC | 72603-913 |
| Clozapine | Clozapine 25 mg/1 | TabletOral | NorthStar Rx LLC | 72603-911 |
| Clozapine | Clozapine 50 mg/1 | TabletOral | NorthStar Rx LLC | 72603-912 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | NorthStar Rx LLC | 72603-914 |
| Clozapine | Clozapine 50 mg/1 | TabletOral | American Health Packaging | 60687-548 |
| Clozapine | Clozapine 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-845 |
| Clozapine | Clozapine 25 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-844 |
| Clozapine | Clozapine 100 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-846 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-847 |
| Clozapine | Clozapine 100 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7087 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7088 |
| Clozapine | Clozapine 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7089 |
| Clozapine | Clozapine 50 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7406 |
| Clozapine | Clozapine 25 mg/1 | TabletOral | American Health Packaging | 60687-404 |
| Clozapine | Clozapine 100 mg/1 | TabletOral | American Health Packaging | 60687-415 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | American Health Packaging | 60687-426 |