Prescription drug · ANDA
Olanzapine Intramuscular (olanzapine) NDC 72843-576
Olanzapine 10 mg/2mL · Injection, Powder, For solution · Intramuscular · UBI Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72843-576-01 | 72843057601 | 1 VIAL in 1 CARTON (72843-576-01) / 2 mL in 1 VIALMarketed from May 8, 2020 |
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 IntramuscularSuffix: Intramuscular
- Generic name (nonproprietary)
- olanzapine
- Active ingredients
- Olanzapine — 10 mg/2mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular
- Labeler
- UBI Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211072
- Marketing start
- Listing expires
- Identifiers
- Product ID 72843-576_4dd1ba70-4209-9711-e063-6294a90ae979SPL ID 4dd1ba70-4209-9711-e063-6294a90ae979SPL set ID 6a279fe1-ed99-4a62-b2c7-831961470fa9RxCUI 485968UNII N7U69T4SZRUPC 0072843576011
- 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
N472843057601followed by a unit qualifier and the quantityPackage 72843-0576-01. 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 Olanzapine for Injection for the: 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 ag…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211072
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 | XGen Pharmaceuticals DJB, Inc. | 39822-1800 |
| Olanzapine Intramuscularolanzapine | Olanzapine 10 mg/2mL | Injection, Powder, For solutionIntramuscular | PAI Holdings, LLC dba PAI Pharma | 0121-1072 |