Prescription drug · ANDA
Olanzapine NDC 67184-0563
Olanzapine 7.5 mg/1 · Tablet · Oral · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC DirectoryProduct 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 204319
- Marketing start
- Listing expires
- Identifiers
- Product ID 67184-0563_69558fe2-90b3-411a-89bb-2405d37d4998SPL ID 69558fe2-90b3-411a-89bb-2405d37d4998SPL set ID 6077f5c4-01d7-4c1d-97a0-cb859f98ce68RxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII N7U69T4SZRUPC 0367184056415
- 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.
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) Adults: Efficacy w…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204319
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 | TabletOral | Qilu Pharmaceutical Co., Ltd. | 67184-0566 |
| Olanzapine | Olanzapine 10 mg/1 | TabletOral | Qilu Pharmaceutical Co., Ltd. | 67184-0564 |
| Olanzapine | Olanzapine 15 mg/1 | TabletOral | Qilu Pharmaceutical Co., Ltd. | 67184-0565 |
| Olanzapine | Olanzapine 5 mg/1 | TabletOral | Qilu Pharmaceutical Co., Ltd. | 67184-0562 |
| Olanzapine | Olanzapine 2.5 mg/1 | TabletOral | Qilu Pharmaceutical Co., Ltd. | 67184-0561 |