Prescription drug · ANDA
Clozapine NDC 51079-288
Clozapine 100 mg/1 · Tablet, Orally disintegrating · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-288-04 | 5107902880451079028804 | 40 BLISTER PACK in 1 CARTON (51079-288-04) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-288-01)Marketed from Sep 26, 2016 |
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 — 100 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Mylan Institutional Inc.NDC labeler code 51079
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201824
- Marketing start
- Listing expires
- Identifiers
- Product ID 51079-288_3a39cd16-5a3c-3d37-e063-6294a90abfc2SPL ID 3a39cd16-5a3c-3d37-e063-6294a90abfc2SPL set ID 976be6e3-a9db-49c6-9b02-1ab168cf17b1RxCUI 476177UNII 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
N451079028804followed by a unit qualifier and the quantityPackage 51079-0288-04. 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 are an atypical antipsychotic indicated for: Treatment-resistant schizophrenia. Efficacy was established in an active-controlled study ( 1.1 , 14.1 ). Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Efficacy was established in an active-controlled study ( 1.2 , 14.2 ). 1.1 Treatment-Resistant Schizophrenia Clozapine orally disintegrating tablets are indicated for the 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 orally disintegrating tablets should…
Excerpt only. Read the full label for complete information.
About NDC 51079-288
- What is NDC 51079-288?
- 51079-288 is the product NDC for Clozapine, Clozapine 100 mg/1 tablet, orally disintegrating, listed with the FDA by Mylan Institutional 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 Institutional Inc., NDC labeler code 51079. 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 150 mg/1 | Tablet, Orally disintegratingOral | Mylan Pharmaceuticals Inc. | 0378-3816 |
| 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 |