Prescription drug · ANDA
Olanzapine NDC 0781-3159
Olanzapine 10 mg/2mL · Injection, Powder, For solution · Intramuscular · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3159-72 | 00781315972 | 1 VIAL in 1 CARTON (0781-3159-72) / 2 mL in 1 VIALMarketed from Oct 24, 2011 |
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 — 10 mg/2mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201588
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-3159_e958c285-a1f2-4f4f-a864-50133543f41cSPL ID e958c285-a1f2-4f4f-a864-50133543f41cSPL set ID 1e9666ef-4271-4834-8496-ccb3125d83dbRxCUI 485968UNII N7U69T4SZRUPC 0307813159728
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400781315972followed by a unit qualifier and the quantityPackage 00781-3159-72. 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 for injection is an atypical antipsychotic indicated: • Treatment of acute agitation associated with schizophrenia and bipolar I mania. ( 1.4 ) • Efficacy was established in three 1-day trials in adults. ( 14.3 ) 1.4 Olanzapine for Injection: Agitation Associated with Schizophrenia and Bipolar I Mania Olanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was demonstrated in 3 short-term (24 hours of IM treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolar I disorder (manic or mixed episodes) [see Clinical Studies ( 14.3 )]. “Psychomotor agitation” is defined …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201588
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/2mL | Injection, Powder, For solutionIntramuscular | Sandoz Inc | 0781-9105 |