fluoxetine

Generic: fluoxetine hydrochloride

Labeler: marksans pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler marksans pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-147
Product ID 25000-147_46219345-2dd8-4502-a0fc-1631e354dc98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075465
Listing Expiration 2026-12-31
Marketing Start 2022-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000147
Hyphenated Format 25000-147

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0325000149123 0325000148140 0325000147037 0325000149086 0325000147082 0325000148089 0325000147143
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 ANDA075465 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (25000-147-03)
  • 100 CAPSULE in 1 BOTTLE (25000-147-08)
  • 1000 CAPSULE in 1 BOTTLE (25000-147-14)
source: ndc

Packages (3)

25000-147-03 30 CAPSULE in 1 BOTTLE (25000-147-03) 25000-147-08 100 CAPSULE in 1 BOTTLE (25000-147-08) 25000-147-14 1000 CAPSULE in 1 BOTTLE (25000-147-14)

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": "46219345-2dd8-4502-a0fc-1631e354dc98", "openfda": {"upc": ["0325000149123", "0325000148140", "0325000147037", "0325000149086", "0325000147082", "0325000148089", "0325000147143"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["8e822937-9431-446f-88c4-330a25d12439"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (25000-147-03)", "package_ndc": "25000-147-03", "marketing_start_date": "20220129"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (25000-147-08)", "package_ndc": "25000-147-08", "marketing_start_date": "20220129"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (25000-147-14)", "package_ndc": "25000-147-14", "marketing_start_date": "20220219"}], "brand_name": "Fluoxetine", "product_id": "25000-147_46219345-2dd8-4502-a0fc-1631e354dc98", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "25000-147", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA075465", "marketing_category": "ANDA", "marketing_start_date": "20220129", "listing_expiration_date": "20261231"}