Prescription drug · ANDA
Olanzapine NDC 70518-1501
Olanzapine 15 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1501-0 | 70518150100 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1501-0)Marketed from Oct 8, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076133
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-1501_5604894c-29a5-d76d-e063-6294a90a1eb3SPL ID 5604894c-29a5-d76d-e063-6294a90a1eb3SPL set ID 1705bab2-a2f8-4534-b1fc-eb309cd2696bRxCUI 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
N470518150100followed by a unit qualifier and the quantityPackage 70518-1501-00. 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 15 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Ltd. | 55111-167 |
| 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 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 |