Prescription drug · ANDA
Olanzapine NDC 0527-3161
Olanzapine 5 mg/1 · Tablet, Orally disintegrating · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-3161-32 | 00527316132 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0527-3161-32)Marketed from Jul 1, 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)
- Olanzapine
- Generic name (nonproprietary)
- olanzapine
- Active ingredients
- Olanzapine — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208146
- Marketing start
- Listing expires
- Identifiers
- Product ID 0527-3161_002da62b-aec3-8e2a-e063-6294a90a5efcSPL ID 002da62b-aec3-8e2a-e063-6294a90a5efcSPL set ID 002dd00f-7946-ea4f-e063-6294a90a5916RxCUI 312076, 314155, 351107, 351108UNII N7U69T4SZRUPC 0305273163323, 0305273164320, 0305273161329, 0305273162326
- 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
N400527316132followed by a unit qualifier and the quantityPackage 00527-3161-32. 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)
Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) Adults: Effi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208146
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 |
|---|---|---|---|---|
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | Lannett Company, Inc. | 0527-3162 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | Lannett Company, Inc. | 0527-3164 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Lannett Company, Inc. | 0527-3163 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | HEC Pharm USA Inc. | 72303-0843 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | HEC Pharm USA Inc. | 72303-0841 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | HEC Pharm USA Inc. | 72303-0842 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | HEC Pharm USA Inc. | 72303-0844 |