fluoxetine

Generic: fluoxetine hydrochloride

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

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler sciegen pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-114
Product ID 50228-114_46055a53-5131-73e6-e063-6394a90ac1db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2015-03-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228114
Hyphenated Format 50228-114

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0350228115056 0350228115018 0350228113106 0350228115308 0350228114011 0350228113014 0350228114103 0350228113052
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 hydrochloride (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (50228-114-01)
  • 500 CAPSULE in 1 BOTTLE (50228-114-05)
  • 1000 CAPSULE in 1 BOTTLE (50228-114-10)
  • 30 CAPSULE in 1 BOTTLE (50228-114-30)
source: ndc

Packages (4)

50228-114-01 100 CAPSULE in 1 BOTTLE (50228-114-01) 50228-114-05 500 CAPSULE in 1 BOTTLE (50228-114-05) 50228-114-10 1000 CAPSULE in 1 BOTTLE (50228-114-10) 50228-114-30 30 CAPSULE in 1 BOTTLE (50228-114-30)

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": "46055a53-5131-73e6-e063-6394a90ac1db", "openfda": {"upc": ["0350228115056", "0350228115018", "0350228113106", "0350228115308", "0350228114011", "0350228113014", "0350228114103", "0350228113052"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["23899405-007b-48d9-82a9-a530b8e90784"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (50228-114-01)", "package_ndc": "50228-114-01", "marketing_start_date": "20150316"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (50228-114-05)", "package_ndc": "50228-114-05", "marketing_start_date": "20150316"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (50228-114-10)", "package_ndc": "50228-114-10", "marketing_start_date": "20150316"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (50228-114-30)", "package_ndc": "50228-114-30", "marketing_start_date": "20150316"}], "brand_name": "Fluoxetine", "product_id": "50228-114_46055a53-5131-73e6-e063-6394a90ac1db", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50228-114", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20150316", "listing_expiration_date": "20261231"}