Prescription drug · ANDA
Olanzapine NDC 68788-7161
Olanzapine 5 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7161-3 | 68788716103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7161-3)Marketed from Jun 5, 2018 | |
| 68788-7161-6 | 68788716106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7161-6)Marketed from Jun 5, 2018 | |
| 68788-7161-9 | 68788716109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7161-9)Marketed from Jun 5, 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202862
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-7161_21f5c530-cee9-4752-aab5-4d100fa6f391SPL ID 21f5c530-cee9-4752-aab5-4d100fa6f391SPL set ID 5bded04a-d848-4ac6-b7c3-ff9b9fef3d29RxCUI 312078UNII 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
N468788716103followed by a unit qualifier and the quantityPackage 68788-7161-03. 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 13-17): 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 ) · Ad…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202862
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 | REMEDYREPACK INC. | 70518-4729 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0072 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8566 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0921 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0935 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-340 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-341 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0525 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2337 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-364 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-478 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2375 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0534 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0690 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9661 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2262 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-487 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-155 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-154 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-156 |
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