Prescription drug · ANDA
Olanzapine NDC 0143-9199
Olanzapine 10 mg/2mL · Injection, Powder, For solution · Intramuscular · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9199-01 | 00143919901 | 1 VIAL in 1 CARTON (0143-9199-01) / 2 mL in 1 VIALMarketed from Sep 18, 2025 |
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
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218116
- Marketing start
- Listing expires
- Identifiers
- Product ID 0143-9199_c6ff3b59-0671-447c-b602-3c97e844d6e8SPL ID c6ff3b59-0671-447c-b602-3c97e844d6e8SPL set ID 63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d1RxCUI 485968UNII 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 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
N400143919901followed by a unit qualifier and the quantityPackage 00143-9199-01. 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 def…
Excerpt only. Read the full label for complete information.
About NDC 0143-9199
- What is NDC 0143-9199?
- 0143-9199 is the product NDC for Olanzapine, Olanzapine 10 mg/2mL injection, powder, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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?
- 200 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 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 15 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc. | 69452-563 | 69452-0563-13 |
| 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 |
Other NDCs under ANDA 218116
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 | Qilu Pharmaceutical Co., Ltd. | 67184-0573 |