fluoxetine hcl

Generic: fluoxetine hcl

Labeler: almatica pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hcl
Generic Name fluoxetine hcl
Labeler almatica pharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 60 mg/1

Manufacturer
Almatica Pharma Inc.

Identifiers & Regulatory

Product NDC 52427-576
Product ID 52427-576_35b885fa-af27-6ad1-f814-025e79a848e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202133
Marketing Start 2017-09-01
Marketing End 2026-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52427576
Hyphenated Format 52427-576

Supplemental Identifiers

RxCUI
1190110
UPC
0352427576300
UNII
I9W7N6B1KJ

Packaging Origin

Original Packager
true

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 hcl (source: ndc)
Generic Name fluoxetine hcl (source: ndc)
Application Number NDA202133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (52427-576-30)
source: ndc

Packages (1)

52427-576-30 30 TABLET, FILM COATED in 1 BOTTLE (52427-576-30)

Ingredients (1)

fluoxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Fluoxetine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35b885fa-af27-6ad1-f814-025e79a848e2", "openfda": {"upc": ["0352427576300"], "unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["b47b291f-3340-0c2a-3585-0926b9c1a71f"], "manufacturer_name": ["Almatica Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (52427-576-30)", "package_ndc": "52427-576-30", "marketing_end_date": "20260401", "marketing_start_date": "20170901"}], "brand_name": "Fluoxetine HCl", "product_id": "52427-576_35b885fa-af27-6ad1-f814-025e79a848e2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "52427-576", "generic_name": "Fluoxetine HCl", "labeler_name": "Almatica Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine HCl", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "NDA202133", "marketing_category": "NDA", "marketing_end_date": "20260401", "marketing_start_date": "20170901"}