Prescription drug · ANDA
Clozapine NDC 0093-5419
Clozapine 100 mg/1 · Tablet, Orally disintegrating · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5419-01 | 0009354190100093541901 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5419-01)Marketed from Jul 25, 2017 | |
| 0093-5419-84 | 0009354198400093541984 | 48 BLISTER PACK in 1 CARTON (0093-5419-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5419-19)Marketed from Jul 25, 2017 |
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, Orally disintegrating
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090308
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-5419_1b735bc2-6341-40af-8696-e61621d91ee8SPL ID 1b735bc2-6341-40af-8696-e61621d91ee8SPL set ID 6fccf4f7-2e30-4272-9800-225aaef20584RxCUI 476177, 476179, 721773, 996921, 1006801UNII 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
N400093541901followed by a unit qualifier and the quantityPackage 00093-5419-01. 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 Tablet…
Excerpt only. Read the full label for complete information.
About NDC 0093-5419
- What is NDC 0093-5419?
- 0093-5419 is the product NDC for Clozapine, Clozapine 100 mg/1 tablet, orally disintegrating, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 090308
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 150 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-5376 |
| Clozapine | Clozapine 200 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-5377 |
| Clozapine | Clozapine 12.5 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-5416 |
| Clozapine | Clozapine 25 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-5417 |