Prescription drug · ANDA
Olanzapine NDC 55150-308
Olanzapine 10 mg/1 · Injection, Powder, Lyophilized, For solution · Intramuscular · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-308-01 | 5515003080155150030801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Oct 22, 2020 | |
| 55150-308-10 | 5515003081055150030810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Oct 22, 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
- Generic name (nonproprietary)
- olanzapine
- Active ingredients
- Olanzapine — 10 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210968
- Marketing start
- Listing expires
- Identifiers
- Product ID 55150-308_3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6SPL ID 3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6SPL set ID 9c745e2e-89d3-44d4-906e-704705c33310RxCUI 485968UNII N7U69T4SZRUPC 0355150308101, 0355150308019
- 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
N455150030801followed by a unit qualifier and the quantityPackage 55150-0308-01. 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 for Injection is an atypical antipsychotic indicated 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 agitation” is defin…
Excerpt only. Read the full label for complete information.
About NDC 55150-308
- What is NDC 55150-308?
- 55150-308 is the product NDC for Olanzapine, Olanzapine 10 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. It has 2 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?
- Eugia US LLC, NDC labeler code 55150. 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 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 20 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-564 | 69452-0564-13 |
| 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 |