NDC 0002-3230

Symbyax

Olanzapine And Fluoxetine Hydrochloride

Symbyax is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Olanzapine; Fluoxetine Hydrochloride.

• Product ID: 0002-3230_087c16dc-e0c2-4c5b-8cc8-f703a992f5d9
• NDC: 0002-3230
• Product Type: Human Prescription Drug
• Proprietary Name: Symbyax
• Generic Name: Olanzapine And Fluoxetine Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2007-04-09
• Marketing Category: NDA / NDA
• Application Number: NDA021520
• Labeler Name: Eli Lilly and Company
• Substance Name: OLANZAPINE; FLUOXETINE HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/1; mg/1
• Pharm Classes: Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0002-3230-30

30 CAPSULE in 1 BOTTLE (0002-3230-30)

• Marketing Start Date: 2007-04-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0002-3230-30 [00002323030]

Symbyax CAPSULE

• Marketing Category: NDA
• Application Number: NDA021520
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-04-09

NDC 0002-3230-07 [00002323007]

Symbyax CAPSULE

• Marketing Category: NDA
• Application Number: NDA021520
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-06-29
• Marketing End Date: 2014-04-02

Drug Details

Active Ingredients

Ingredient	Strength
OLANZAPINE	3 mg/1

OpenFDA Data

• SPL SET ID: 6b28c424-0b7e-4b75-b090-f116b113554e
• Manufacturer:
  • Eli Lilly and Company
• UNII:
  • I9W7N6B1KJ
  • N7U69T4SZR
• RxNorm Concept Unique ID - RxCUI:
  • 725080
  • 725064
  • 725072
  • 725076
  • 403969
  • 721787
  • 725068
  • 403972
  • 403971
  • 403970
• UPC Code:
  • 0300023233301
  • 0300023230300
  • 0300023231307
  • 0300023232304
  • 0300023234308

Pharmacological Class

• Atypical Antipsychotic [EPC]
• Serotonin Reuptake Inhibitor [EPC]
• Serotonin Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Symbyax" or generic name "Olanzapine And Fluoxetine Hydrochloride"

NDC	Brand Name	Generic Name
0002-3230	Symbyax	Olanzapine and Fluoxetine hydrochloride
0002-3231	Symbyax	Olanzapine and Fluoxetine hydrochloride
0002-3232	Symbyax	Olanzapine and Fluoxetine hydrochloride
0002-3233	Symbyax	Olanzapine and Fluoxetine hydrochloride
0002-3234	Symbyax	Olanzapine and Fluoxetine hydrochloride