fluoxetine

Generic: fluoxetine

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0313
Product ID 80425-0313_2a9bf7d3-46d9-0dfa-e063-6394a90a76a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2023-04-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250313
Hyphenated Format 80425-0313

Supplemental Identifiers

RxCUI
310385
UNII
I9W7N6B1KJ

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 ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0313-1)
  • 60 CAPSULE in 1 BOTTLE (80425-0313-2)
  • 90 CAPSULE in 1 BOTTLE (80425-0313-3)
source: ndc

Packages (3)

80425-0313-1 30 CAPSULE in 1 BOTTLE (80425-0313-1) 80425-0313-2 60 CAPSULE in 1 BOTTLE (80425-0313-2) 80425-0313-3 90 CAPSULE in 1 BOTTLE (80425-0313-3)

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": "2a9bf7d3-46d9-0dfa-e063-6394a90a76a4", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310385"], "spl_set_id": ["f917063a-226e-0978-e053-6294a90aeb4b"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0313-1)", "package_ndc": "80425-0313-1", "marketing_start_date": "20230411"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (80425-0313-2)", "package_ndc": "80425-0313-2", "marketing_start_date": "20230411"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (80425-0313-3)", "package_ndc": "80425-0313-3", "marketing_start_date": "20230411"}], "brand_name": "Fluoxetine", "product_id": "80425-0313_2a9bf7d3-46d9-0dfa-e063-6394a90a76a4", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "80425-0313", "generic_name": "Fluoxetine", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "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": "20230411", "listing_expiration_date": "20261231"}