fluoxetine

Generic: fluoxetine hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8183
Product ID 0615-8183_1cbaceb2-e30c-4a5d-b4af-bf614d41b348
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Marketing Start 2008-01-31
Marketing End 2026-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158183
Hyphenated Format 0615-8183

Supplemental Identifiers

RxCUI
313989
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 hydrochloride (source: ndc)
Application Number ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 CAPSULE in 1 BLISTER PACK (0615-8183-05)
  • 30 CAPSULE in 1 BLISTER PACK (0615-8183-39)
source: ndc

Packages (2)

0615-8183-05 15 CAPSULE in 1 BLISTER PACK (0615-8183-05) 0615-8183-39 30 CAPSULE in 1 BLISTER PACK (0615-8183-39)

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": "1cbaceb2-e30c-4a5d-b4af-bf614d41b348", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["9f069b9b-16e4-4f0e-b420-4aa02ffbb632"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BLISTER PACK (0615-8183-05)", "package_ndc": "0615-8183-05", "marketing_end_date": "20261031", "marketing_start_date": "20230911"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (0615-8183-39)", "package_ndc": "0615-8183-39", "marketing_end_date": "20261031", "marketing_start_date": "20180322"}], "brand_name": "Fluoxetine", "product_id": "0615-8183_1cbaceb2-e30c-4a5d-b4af-bf614d41b348", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0615-8183", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_end_date": "20261031", "marketing_start_date": "20080131"}