Prescription drug · ANDA
Olanzapine NDC 60429-622
Olanzapine 7.5 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60429-622-10 | 60429062210 | 1000 TABLET, FILM COATED in 1 BOTTLE (60429-622-10)Marketed from Oct 16, 2019 | |
| 60429-622-30 | 60429062230 | 30 TABLET, FILM COATED in 1 BOTTLE (60429-622-30)Marketed from Oct 16, 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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090798
- Marketing start
- Listing expires
- Identifiers
- Product ID 60429-622_5023a1ed-b0d6-44d2-e063-6394a90ae2c3SPL ID 5023a1ed-b0d6-44d2-e063-6394a90ae2c3SPL set ID a1dfb4e7-4143-4422-b7a7-292e4fd75044RxCUI 200034, 283639, 312077, 312078, 312079, 314154UNII 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
N460429062210followed by a unit qualifier and the quantityPackage 60429-0622-10. 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 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 bipolar I disorder. ( 1.2 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090798
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 2.5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3110 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3114 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3111 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3112 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3113 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3140 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-620 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-621 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-624 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-623 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-625 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-429 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-453 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-844 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3568 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6693 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-419 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-067 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2599 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0314 |