Prescription drug · ANDA
Olanzapine NDC 59746-307
Olanzapine 10 mg/1 · Tablet, Orally disintegrating · Oral · Jubilant Cadista Pharmacuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59746-307-32 | 59746030732 | 3 BLISTER PACK in 1 CARTON (59746-307-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-307-12)Marketed from Sep 13, 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 — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200221
- Marketing start
- Listing expires
- Identifiers
- Product ID 59746-307_fddf60eb-156f-4e8c-9bad-3942d714fdceSPL ID fddf60eb-156f-4e8c-9bad-3942d714fdceSPL set ID 028aa88e-fa50-7aa8-cc0b-97c0c9a0357cRxCUI 312076, 314155, 351107, 351108UNII N7U69T4SZRUPC 0359746307325, 0359746306328, 0359746309329, 0359746308322
- 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
N459746030732followed by a unit qualifier and the quantityPackage 59746-0307-32. 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 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200221
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, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-306 |
| Olanzapine | Olanzapine 15 mg/1 | Tablet, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-308 |
| Olanzapine | Olanzapine 20 mg/1 | Tablet, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-309 |