Prescription drug · NDA
ZYPREXA Zydis (olanzapine) NDC 61269-650
Olanzapine 5 mg/1 · Tablet, Orally disintegrating · Oral · H2-Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-650-35 | 61269065035 | 30 DOSE PACK in 1 CARTON (61269-650-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-650-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jun 1, 2000 |
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)
- ZYPREXA ZydisSuffix: Zydis
- Generic name (nonproprietary)
- olanzapine
- Active ingredients
- Olanzapine — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- H2-Pharma LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021086
- Marketing start
- Listing expires
- Identifiers
- Product ID 61269-650_40d4ed67-c51d-40d0-8a32-ecfdbf069f9aSPL ID 40d4ed67-c51d-40d0-8a32-ecfdbf069f9aSPL set ID b418946a-1ab4-4d89-a012-d94fc361a3c4RxCUI 153046, 153047, 153048, 200034, 212405, 261337, 283639, 284514, 312076, 312077, 312078, 312079, 314154, 314155, 351107, 351108, 485968, 545353, 754503, 754504, 754505, 754506UNII N7U69T4SZRUPC 0361269633300, 0361269635304, 0361269634307, 0361269630309, 0361269632303, 0361269631306
- 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
N461269065035followed by a unit qualifier and the quantityPackage 61269-0650-35. 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)
ZYPREXA ® (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 ) …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021086
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 |
|---|---|---|---|---|
| ZYPREXA Zydisolanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-651 |
| ZYPREXA Zydisolanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-652 |
| ZYPREXA Zydisolanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | H2-Pharma LLC | 61269-653 |