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 TABLET
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 60 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-638
Product ID 50228-638_3e89095f-77b2-4fde-e063-6294a90a1ff3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211282
Listing Expiration 2026-12-31
Marketing Start 2025-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228638
Hyphenated Format 50228-638

Supplemental Identifiers

RxCUI
1190110
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 ANDA211282 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (50228-638-10)
  • 30 TABLET in 1 BOTTLE (50228-638-30)
source: ndc

Packages (2)

50228-638-10 1000 TABLET in 1 BOTTLE (50228-638-10) 50228-638-30 30 TABLET in 1 BOTTLE (50228-638-30)

Ingredients (1)

fluoxetine hydrochloride (60 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": "3e89095f-77b2-4fde-e063-6294a90a1ff3", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["3e8912e2-2a0c-5047-e063-6294a90a7e32"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-638-10)", "package_ndc": "50228-638-10", "marketing_start_date": "20250911"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-638-30)", "package_ndc": "50228-638-30", "marketing_start_date": "20250911"}], "brand_name": "Fluoxetine", "product_id": "50228-638_3e89095f-77b2-4fde-e063-6294a90a1ff3", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50228-638", "generic_name": "FLUOXETINE HYDROCHLORIDE", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211282", "marketing_category": "ANDA", "marketing_start_date": "20250911", "listing_expiration_date": "20261231"}