fluoxetine

Generic: fluoxetine

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
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-7625
Product ID 0615-7625_e0e2906e-e311-4a3d-a9bd-3764f1b4cf34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076001
Listing Expiration 2026-12-31
Marketing Start 2002-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06157625
Hyphenated Format 0615-7625

Supplemental Identifiers

RxCUI
310384 310385
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 ANDA076001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 15 CAPSULE in 1 BLISTER PACK (0615-7625-05)
  • 30 CAPSULE in 1 BLISTER PACK (0615-7625-39)
source: ndc

Packages (2)

0615-7625-05 15 CAPSULE in 1 BLISTER PACK (0615-7625-05) 0615-7625-39 30 CAPSULE in 1 BLISTER PACK (0615-7625-39)

Ingredients (1)

fluoxetine hydrochloride (20 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": "e0e2906e-e311-4a3d-a9bd-3764f1b4cf34", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385"], "spl_set_id": ["647e17f5-a15a-4e77-922c-24a5db2118bc"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BLISTER PACK (0615-7625-05)", "package_ndc": "0615-7625-05", "marketing_start_date": "20190415"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (0615-7625-39)", "package_ndc": "0615-7625-39", "marketing_start_date": "20110520"}], "brand_name": "Fluoxetine", "product_id": "0615-7625_e0e2906e-e311-4a3d-a9bd-3764f1b4cf34", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0615-7625", "generic_name": "Fluoxetine", "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": "20 mg/1"}], "application_number": "ANDA076001", "marketing_category": "ANDA", "marketing_start_date": "20020129", "listing_expiration_date": "20261231"}