Prescription drug · ANDA
Olanzapine NDC 0093-5245
Olanzapine 5 mg/1 · Tablet, Orally disintegrating · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5245-65 | 00093524565 | 30 BLISTER PACK in 1 CARTON (0093-5245-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5245-19)Marketed from Feb 17, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077243
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-5245_379692bf-82b3-48f3-8d1f-5a27949ce441SPL ID 379692bf-82b3-48f3-8d1f-5a27949ce441SPL set ID dd0b2525-4e2f-44fc-9302-0ae4ebb1e135RxCUI 312076, 314155, 351107, 351108UNII 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
N400093524565followed by a unit qualifier and the quantityPackage 00093-5245-65. 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 bipola…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077243
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 20 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-5248 |
| Olanzapine | Olanzapine 10 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-5246 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Teva Pharmaceuticals USA, Inc. | 0093-5247 |