Prescription drug · ANDA
Olanzapine NDC 68084-525
Olanzapine 2.5 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-525-01 | 68084052501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-525-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-525-11)Marketed from May 1, 2012 |
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 — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076255
- Marketing start
- Listing expires
- Identifiers
- Product ID 68084-525_4198cdd2-0af7-d4da-e063-6394a90a4142SPL ID 4198cdd2-0af7-d4da-e063-6394a90a4142SPL set ID 75616c31-8fed-4014-a9f2-4a028eccd586RxCUI 200034, 312078, 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
N468084052501followed by a unit qualifier and the quantityPackage 68084-0525-01. 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 ) Adults: E…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076255
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 7.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0363 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2627 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Ltd. | 55111-163 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-061 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4012 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-062 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0539 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0540 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-723 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-740 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0714 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1611 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1605 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6376 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-460 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1635 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-164 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6377 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6889 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8722 |
Showing 20 of 25.