olanzapine and fluoxetine

Generic: olanzapine and fluoxetine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine and fluoxetine
Generic Name olanzapine and fluoxetine
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 50 mg/1, olanzapine 6 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-654
Product ID 42291-654_4135db41-e022-f3a8-e063-6394a90a3681
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077528
Listing Expiration 2026-12-31
Marketing Start 2014-01-21

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291654
Hyphenated Format 42291-654

Supplemental Identifiers

RxCUI
403969 403970 403971 403972 721787
UPC
0342291656307 0342291654303 0342291655300 0342291653306 0342291652309
UNII
N7U69T4SZR I9W7N6B1KJ
NUI
N0000175430

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olanzapine and fluoxetine (source: ndc)
Generic Name olanzapine and fluoxetine (source: ndc)
Application Number ANDA077528 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 6 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (42291-654-30)
source: ndc

Packages (1)

42291-654-30 30 CAPSULE in 1 BOTTLE (42291-654-30)

Ingredients (2)

fluoxetine hydrochloride (50 mg/1) olanzapine (6 mg/1)

Linked Drug Pages (1)

Olanzapine and Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4135db41-e022-f3a8-e063-6394a90a3681", "openfda": {"nui": ["N0000175430"], "upc": ["0342291656307", "0342291654303", "0342291655300", "0342291653306", "0342291652309"], "unii": ["N7U69T4SZR", "I9W7N6B1KJ"], "rxcui": ["403969", "403970", "403971", "403972", "721787"], "spl_set_id": ["f5f78ed2-4640-8528-c51c-d7bffa045d48"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42291-654-30)", "package_ndc": "42291-654-30", "marketing_start_date": "20140121"}], "brand_name": "Olanzapine and Fluoxetine", "product_id": "42291-654_4135db41-e022-f3a8-e063-6394a90a3681", "dosage_form": "CAPSULE", "pharm_class": ["Atypical Antipsychotic [EPC]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "42291-654", "generic_name": "Olanzapine and Fluoxetine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine and Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "50 mg/1"}, {"name": "OLANZAPINE", "strength": "6 mg/1"}], "application_number": "ANDA077528", "marketing_category": "ANDA", "marketing_start_date": "20140121", "listing_expiration_date": "20261231"}