fluoxetine

Generic: fluoxetine

Labeler: sciegen pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler sciegen pharmaceuticals, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-420
Product ID 50228-420_08a26093-1715-5580-e063-6294a90a4ff6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210935
Listing Expiration 2026-12-31
Marketing Start 2019-03-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228420
Hyphenated Format 50228-420

Supplemental Identifiers

RxCUI
248642 313990
UPC
0350228421102 0350228420105 0350228420303 0350228421010 0350228420013 0350228421300
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 (source: ndc)
Generic Name fluoxetine (source: ndc)
Application Number ANDA210935 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (50228-420-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-420-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-420-30)
source: ndc

Packages (3)

50228-420-01 100 TABLET, FILM COATED in 1 BOTTLE (50228-420-01) 50228-420-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-420-10) 50228-420-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-420-30)

Ingredients (1)

fluoxetine hydrochloride (10 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": "08a26093-1715-5580-e063-6294a90a4ff6", "openfda": {"upc": ["0350228421102", "0350228420105", "0350228420303", "0350228421010", "0350228420013", "0350228421300"], "unii": ["I9W7N6B1KJ"], "rxcui": ["248642", "313990"], "spl_set_id": ["b5035f61-693e-4386-8a07-3c36a6a46917"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50228-420-01)", "package_ndc": "50228-420-01", "marketing_start_date": "20190320"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-420-10)", "package_ndc": "50228-420-10", "marketing_start_date": "20190320"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-420-30)", "package_ndc": "50228-420-30", "marketing_start_date": "20190320"}], "brand_name": "Fluoxetine", "product_id": "50228-420_08a26093-1715-5580-e063-6294a90a4ff6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50228-420", "generic_name": "Fluoxetine", "labeler_name": "ScieGen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA210935", "marketing_category": "ANDA", "marketing_start_date": "20190320", "listing_expiration_date": "20261231"}