Prescription drug · ANDA
Olanzapine NDC 65862-565
Olanzapine 15 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-565-01 | 65862056501 | 100 TABLET in 1 BOTTLE (65862-565-01)Marketed from Apr 23, 2012 | |
| 65862-565-10 | 65862056510 | 10 BLISTER PACK in 1 CARTON (65862-565-10) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 23, 2012 | |
| 65862-565-30 | 65862056530 | 30 TABLET in 1 BOTTLE (65862-565-30)Marketed from Apr 23, 2012 | |
| 65862-565-99 | 65862056599 | 1000 TABLET in 1 BOTTLE (65862-565-99)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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202050
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-565_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
N465862056501followed by a unit qualifier and the quantityPackage 65862-0565-01. 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.
About NDC 65862-565
- What is NDC 65862-565?
- 65862-565 is the product NDC for Olanzapine, Olanzapine 15 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olanzapine.
- What is the active ingredient?
- Olanzapine.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Olanzapine?
- 205 other product NDCs are listed under this name. See all Olanzapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olanzapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0690 | 67046-0690-03 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4729 | 70518-4729-00 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6693 | 55154-6693-00 |
| olanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-564 | 69452-0564-13 |
| olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-563 | 69452-0563-13 |
| olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-561 | 69452-0561-13 |
| olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-562 | 69452-0562-13 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-061 | 87441-0061-01 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-062 | 87441-0062-01 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0072 | 67046-0072-03 |
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 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 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-564 |
| Olanzapine | Olanzapine 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-566 |