Prescription drug · ANDA
Olanzapine NDC 63629-8718
Olanzapine 10 mg/1 · Tablet, Orally disintegrating · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8718-1 | 63629871801 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8718-1)Marketed from Oct 24, 2011 |
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 — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091265
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-8718_3364e551-5f70-d3ba-e063-6394a90afbe1SPL ID 3364e551-5f70-d3ba-e063-6394a90afbe1SPL set ID ed93d6b9-912a-444a-a695-439d0bfb877aRxCUI 312076UNII 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
N463629871801followed by a unit qualifier and the quantityPackage 63629-8718-01. 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 orally disintegrating tablets are 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 bipol…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091265
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 | Tablet, Orally disintegratingOral | Apotex Corp. | 60505-3276 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | Apotex Corp. | 60505-3275 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Apotex Corp. | 60505-3277 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | Apotex Corp. | 60505-3278 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | Golden State Medical Supply, Inc. | 51407-262 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | Golden State Medical Supply, Inc. | 51407-261 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Golden State Medical Supply, Inc. | 51407-263 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | Golden State Medical Supply, Inc. | 51407-264 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | Coupler LLC | 67046-1550 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | Coupler LLC | 67046-1565 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 63629-8714 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 63629-8717 |