fluoxetine

Generic: fluoxetine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fluoxetine hydrochloride 40 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-398
Product ID 42291-398_485cea96-1faf-10cf-e063-6294a90a82e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075452
Marketing Start 2017-08-14
Marketing End 2026-03-31

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291398
Hyphenated Format 42291-398

Supplemental Identifiers

RxCUI
313989
UPC
0342291398504
UNII
I9W7N6B1KJ

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 fluoxetine (source: ndc)
Generic Name fluoxetine (source: ndc)
Application Number ANDA075452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (42291-398-50)
source: ndc

Packages (1)

42291-398-50 500 CAPSULE in 1 BOTTLE (42291-398-50)

Ingredients (1)

fluoxetine hydrochloride (40 mg/1)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "485cea96-1faf-10cf-e063-6294a90a82e3", "openfda": {"upc": ["0342291398504"], "unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["2a6581fc-d458-4bb3-97fa-2179405599ca"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42291-398-50)", "package_ndc": "42291-398-50", "marketing_end_date": "20260331", "marketing_start_date": "20170814"}], "brand_name": "Fluoxetine", "product_id": "42291-398_485cea96-1faf-10cf-e063-6294a90a82e3", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "42291-398", "generic_name": "Fluoxetine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA075452", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20170814"}