Prescription drug · ANDA
Olanzapine NDC 55154-6881
Olanzapine 5 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-6881-0 | 55154688100 | 10 BLISTER PACK in 1 BAG (55154-6881-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 23, 2012 |
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
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076255
- Marketing start
- Listing expires
- Identifiers
- Product ID 55154-6881_422164eb-480b-4052-88cd-634678f1a734SPL ID 422164eb-480b-4052-88cd-634678f1a734SPL set ID 38a89689-efc2-4931-8f65-868dc0248d6aRxCUI 312078, 314154UNII N7U69T4SZRUPC 0055154688901, 0055154688109
- 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
N455154688100followed by a unit qualifier and the quantityPackage 55154-6881-00. 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 6week 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 ) • Adu…
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 5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-164 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6889 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-460 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-165 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-166 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0110 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8722 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1764 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2627 |
| Olanzapine | Olanzapine 7.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0363 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Ltd. | 55111-163 |
| Olanzapine | Olanzapine 5 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-062 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-061 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-525 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0539 |
| Olanzapine | Olanzapine 2.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4012 |
| 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 |
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