Prescription drug · ANDA
Olanzapine NDC 65862-566
Olanzapine 20 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-566-01 | 65862056601 | 100 TABLET in 1 BOTTLE (65862-566-01)Marketed from Apr 23, 2012 | |
| 65862-566-05 | 65862056605 | 500 TABLET in 1 BOTTLE (65862-566-05)Marketed from Apr 23, 2012 | |
| 65862-566-10 | 65862056610 | 10 BLISTER PACK in 1 CARTON (65862-566-10) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 23, 2012 | |
| 65862-566-30 | 65862056630 | 30 TABLET in 1 BOTTLE (65862-566-30)Marketed from Apr 23, 2012 | |
| 65862-566-99 | 65862056699 | 1000 TABLET in 1 BOTTLE (65862-566-99)Marketed from Apr 23, 2012 |
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)
- Olanzapine
- Generic name (nonproprietary)
- olanzapine
- Active ingredients
- Olanzapine — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202050
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-566_e10b90de-4a0a-413e-a5f9-6978a183b568SPL ID e10b90de-4a0a-413e-a5f9-6978a183b568SPL set ID 636665be-9d7e-443a-8134-e8cc47e6ba24RxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII N7U69T4SZR
- 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
N465862056601followed by a unit qualifier and the quantityPackage 65862-0566-01. 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)
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 to 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: E…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202050
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 | TabletOral | Bryant Ranch Prepack | 71335-1936 |
| Olanzapine | Olanzapine 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-564 |
| Olanzapine | Olanzapine 2.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-561 |
| Olanzapine | Olanzapine 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-562 |
| Olanzapine | Olanzapine 7.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-563 |
| Olanzapine | Olanzapine 15 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-565 |