Prescription drug · ANDA
Olanzapine and Fluoxetine NDC 42291-653
Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-653-30 | 42291065330 | 30 CAPSULE in 1 BOTTLE (42291-653-30)Marketed from Jan 21, 2014 |
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 and Fluoxetine
- Generic name (nonproprietary)
- olanzapine and fluoxetine
- Active ingredients
- Olanzapine — 6 mg/1Fluoxetine hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077528
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 42291-653_4135db41-e022-f3a8-e063-6394a90a3681SPL ID 4135db41-e022-f3a8-e063-6394a90a3681SPL set ID f5f78ed2-4640-8528-c51c-d7bffa045d48RxCUI 403969, 403970, 403971, 403972, 721787UNII N7U69T4SZR, I9W7N6B1KJUPC 0342291656307, 0342291654303, 0342291655300, 0342291653306, 0342291652309
- Pharmacologic class
- Atypical Antipsychotic; Serotonin Reuptake Inhibitor
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
N442291065330followed by a unit qualifier and the quantityPackage 42291-0653-30. 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 and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1) ]. Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2) ]. Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder (1) Treatment Resistant Depression (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077528
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 and Fluoxetine | Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | AvKARE | 42291-654 |
| Olanzapine and Fluoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | AvKARE | 42291-655 |
| Olanzapine and Fluoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | AvKARE | 42291-656 |
| Olanzapine and Fluoxetine | Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-5504 |
| Olanzapine and Fluoxetine | Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-5505 |
| Olanzapine and Fluoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-5506 |
| Olanzapine and Fluoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-5507 |