Prescription drug · ANDA
Olanzapine and Fluoxetine NDC 0093-5503
Olanzapine 3 mg/1; Fluoxetine hydrochloride 25 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5503-56 | 0009355035600093550356 | 30 CAPSULE in 1 BOTTLE (0093-5503-56)Marketed from Apr 10, 2013 |
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 and Fluoxetine
- Generic name (nonproprietary)
- olanzapine and fluoxetine
- Active ingredients
- Olanzapine — 3 mg/1Fluoxetine hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202074
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-5503_debcba63-033a-446f-a086-ccdf9d790662SPL ID debcba63-033a-446f-a086-ccdf9d790662SPL set ID 3c28cf18-01a3-468a-ab3e-8aa82f918251RxCUI 403969, 403970, 403971, 403972, 721787UNII I9W7N6B1KJ, N7U69T4SZRUPC 0300935506562, 0300935503561, 0300935505565, 0300935507569, 0300935504568
- 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
N400093550356followed by a unit qualifier and the quantityPackage 00093-5503-56. 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.
About NDC 0093-5503
- What is NDC 0093-5503?
- 0093-5503 is the product NDC for Olanzapine and Fluoxetine, Olanzapine 3 mg/1; Fluoxetine hydrochloride 25 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olanzapine and Fluoxetine.
- What is the active ingredient?
- Olanzapine, Fluoxetine hydrochloride.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Olanzapine and Fluoxetine?
- 14 other product NDCs are listed under this name. See all Olanzapine and Fluoxetine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olanzapine and Fluoxetine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olanzapine and Fluoxetine | Olanzapine 3 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | AvKARE | 42291-652 | 42291-0652-30 |
| Olanzapine and Fluoxetine | Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | AvKARE | 42291-653 | 42291-0653-30 |
| Olanzapine and Fluoxetine | Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | AvKARE | 42291-654 | 42291-0654-30 |
| Olanzapine and Fluoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | AvKARE | 42291-655 | 42291-0655-30 |
| Olanzapine and Fluoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | AvKARE | 42291-656 | 42291-0656-30 |
| Olanzapine and Fluoxetineolanzapine and fuoxetine | Olanzapine 6 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-250 | 49884-0250-11 |
| Olanzapine and Fluoxetineolanzapine and fuoxetine | Olanzapine 6 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-251 | 49884-0251-11 |
| Olanzapine and Fluoxetineolanzapine and fuoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-252 | 49884-0252-11 |
| Olanzapine and Fluoxetineolanzapine and fuoxetine | Olanzapine 12 mg/1; Fluoxetine hydrochloride 50 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-253 | 49884-0253-11 |
| Olanzapine and Fluoxetineolanzapine and fuoxetine | Olanzapine 3 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-277 | 49884-0277-11 |
Other NDCs under ANDA 202074
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 3 mg/1; Fluoxetine hydrochloride 25 mg/1 | CapsuleOral | AvKARE | 42291-652 |