Prescription drug · NDA
Clozaril (Clozapine) NDC 69809-0126
Clozapine 25 mg/1 · Tablet · Oral · HLS Therapeutics (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69809-0126-5 | 6980901260569809012605 | 100 TABLET in 1 BOTTLE (69809-0126-5)Marketed from May 6, 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)
- Clozaril
- Generic name (nonproprietary)
- clozapine
- Active ingredients
- Clozapine — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- HLS Therapeutics (USA), Inc.NDC labeler code 69809
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019758
- Marketing start
- Listing expires
- Identifiers
- Product ID 69809-0126_14601465-eda2-4063-b606-cb6cfcaaca3dSPL ID 14601465-eda2-4063-b606-cb6cfcaaca3dSPL set ID 90876802-0e3a-44c9-9ff7-1754dfbe736aRxCUI 104775, 104776, 197535, 197536UNII J60AR2IKICUPC 0369809012752, 0369809012653
- 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
N469809012605followed by a unit qualifier and the quantityPackage 69809-0126-05. 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)
CLOZARIL 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, CLOZARIL 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 CLOZARIL is indicated for the treatment of severely ill patients with schizophrenia w…
Excerpt only. Read the full label for complete information.
About NDC 69809-0126
- What is NDC 69809-0126?
- 69809-0126 is the product NDC for Clozaril (clozapine), Clozapine 25 mg/1 tablet, listed with the FDA by HLS Therapeutics (USA), Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clozaril (Clozapine).
- What is the active ingredient?
- Clozapine.
- Who is the labeler?
- HLS Therapeutics (USA), Inc., NDC labeler code 69809. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clozaril?
- 1 other product NDC are listed under this name. See all Clozaril NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clozaril products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clozarilclozapine | Clozapine 100 mg/1 | TabletOral | HLS Therapeutics (USA), Inc. | 69809-0127 | 69809-0127-05 |
Other NDCs under NDA 019758
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 |
|---|---|---|---|---|
| Clozarilclozapine | Clozapine 100 mg/1 | TabletOral | HLS Therapeutics (USA), Inc. | 69809-0127 |