Prescription drug · ANDA
Olanzapine NDC 71209-075
Olanzapine 7.5 mg/1 · Tablet · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-075-01 | 71209007501 | 30 TABLET in 1 BOTTLE (71209-075-01)Marketed from Feb 13, 2019 | |
| 71209-075-05 | 71209007505 | 100 TABLET in 1 BOTTLE (71209-075-05)Marketed from Oct 4, 2023 | |
| 71209-075-10 | 71209007510 | 500 TABLET in 1 BOTTLE (71209-075-10)Marketed from Oct 4, 2023 | |
| 71209-075-11 | 71209007511 | 1000 TABLET in 1 BOTTLE (71209-075-11)Marketed from Feb 13, 2019 |
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 — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210022
- Marketing start
- Listing expires
- Identifiers
- Product ID 71209-075_a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6SPL ID a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6SPL set ID 2ae07ad4-4e58-4740-9f02-035ec061fefcRxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII N7U69T4SZRUPC 0371209073011, 0371209076012, 0371209078115, 0371209077019, 0371209074018, 0371209075114, 0371209073110, 0371209076111, 0371209074117
- 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
N471209007501followed by a unit qualifier and the quantityPackage 71209-0075-01. 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 6-week 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 ) •…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210022
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/1 | TabletOral | Coupler LLC | 67046-1583 |
| Olanzapine | Olanzapine 20 mg/1 | TabletOral | Coupler LLC | 67046-1604 |
| Olanzapine | Olanzapine 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1611 |
| Olanzapine | Olanzapine 2.5 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-073 |
| Olanzapine | Olanzapine 5 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-074 |
| Olanzapine | Olanzapine 10 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-054 |
| Olanzapine | Olanzapine 10 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-076 |
| Olanzapine | Olanzapine 2.5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-051 |
| Olanzapine | Olanzapine 15 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-077 |
| Olanzapine | Olanzapine 5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-052 |
| Olanzapine | Olanzapine 20 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-078 |
| Olanzapine | Olanzapine 7.5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-053 |
| Olanzapine | Olanzapine 15 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-055 |
| Olanzapine | Olanzapine 20 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-056 |
| Olanzapine | Olanzapine 15 mg/1 | TabletOral | Coupler LLC | 67046-1653 |