Prescription drug · ANDA
Clozapine NDC 0378-3816
Clozapine 150 mg/1 · Tablet, Orally disintegrating · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-3816-01 | 0037838160100378381601 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3816-01)Marketed from Aug 16, 2023 |
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 — 150 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201824
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-3816_435c523e-e4fc-4653-9eb7-ff9c194b42aeSPL ID 435c523e-e4fc-4653-9eb7-ff9c194b42aeSPL set ID 9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219RxCUI 476177, 476179, 996921, 1006801UNII J60AR2IKICUPC 0303783817019, 0303783816012
- 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
N400378381601followed by a unit qualifier and the quantityPackage 00378-3816-01. 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 Ta…
Excerpt only. Read the full label for complete information.
About NDC 0378-3816
- What is NDC 0378-3816?
- 0378-3816 is the product NDC for Clozapine, Clozapine 150 mg/1 tablet, orally disintegrating, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clozapine.
- What is the active ingredient?
- Clozapine.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clozapine?
- 43 other product NDCs are listed under this name. See all Clozapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clozapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clozapine | Clozapine 25 mg/1 | TabletOral | NorthStar Rx LLC | 72603-911 | 72603-0911-01 |
| Clozapine | Clozapine 50 mg/1 | TabletOral | NorthStar Rx LLC | 72603-912 | 72603-0912-01 |
| Clozapine | Clozapine 100 mg/1 | TabletOral | NorthStar Rx LLC | 72603-913 | 72603-0913-0172603-0913-02 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | NorthStar Rx LLC | 72603-914 | 72603-0914-01 |
| Clozapine | Clozapine 100 mg/1 | Tablet, Orally disintegratingOral | Safecor Health, LLC | 48433-022 | 48433-0022-04 |
| Clozapine | Clozapine 25 mg/1 | TabletOral | Safecor Health LLC | 48433-023 | 48433-0023-20 |
| Clozapine | Clozapine 100 mg/1 | TabletOral | Safecor Health LLC | 48433-024 | 48433-0024-20 |
| Clozapine | Clozapine 200 mg/1 | TabletOral | Safecor Health LLC | 48433-025 | 48433-0025-20 |
| Clozapine | Clozapine 12.5 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-260 | 59651-0260-01 |
| Clozapine | Clozapine 25 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-261 | 59651-0261-0159651-0261-48 |
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 Pharmaceuticals Inc. | 0378-3815 |
| Clozapine | Clozapine 200 mg/1 | Tablet, Orally disintegratingOral | Mylan Pharmaceuticals Inc. | 0378-3817 |
| Clozapine | Clozapine 100 mg/1 | Tablet, Orally disintegratingOral | Safecor Health, LLC | 48433-022 |
| Clozapine | Clozapine 100 mg/1 | Tablet, Orally disintegratingOral | Mylan Institutional Inc. | 51079-288 |