Prescription drug · ANDA
Olanzapine NDC 55111-167
Olanzapine 15 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-167-01 | 55111016701 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-167-01)Marketed from Apr 23, 2012 | |
| 55111-167-05 | 55111016705 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-167-05)Marketed from Apr 23, 2012 | |
| 55111-167-30 | 55111016730 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-167-30)Marketed from Apr 23, 2012 | |
| 55111-167-78 | 55111016778 | 10 BLISTER PACK in 1 CARTON (55111-167-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-167-79)Marketed from Apr 23, 2012 |
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 — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076133
- Marketing start
- Listing expires
- Identifiers
- Product ID 55111-167_2f861c8a-30f2-1080-95fb-1eba71d613b8SPL ID 2f861c8a-30f2-1080-95fb-1eba71d613b8SPL set ID a4c525da-c2f6-b804-af49-601295922254RxCUI 283639, 312077UNII 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 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
N455111016701followed by a unit qualifier and the quantityPackage 55111-0167-01. 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 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 to 17): Efficacy was established in one 6week 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 ) Adults: E…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076133
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 20 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Ltd. | 55111-168 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0524 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-528 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-529 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1501 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1582 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6286 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6287 |