fluoxetine

Generic: fluoxetine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-4721
Product ID 0121-4721_12f427c0-a74a-4af5-ad77-7282d4d70190
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076015
Listing Expiration 2026-12-31
Marketing Start 2002-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01214721
Hyphenated Format 0121-4721

Supplemental Identifiers

RxCUI
310386
UPC
0301210721045
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 ANDA076015 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (0121-4721-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4721-05)
source: ndc

Packages (1)

0121-4721-40 4 TRAY in 1 CASE (0121-4721-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4721-05)

Ingredients (1)

fluoxetine hydrochloride (20 mg/5mL)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12f427c0-a74a-4af5-ad77-7282d4d70190", "openfda": {"upc": ["0301210721045"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["180a07fd-1f6a-4617-b8e0-f938c65ba273"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (0121-4721-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4721-05)", "package_ndc": "0121-4721-40", "marketing_start_date": "20020201"}], "brand_name": "Fluoxetine", "product_id": "0121-4721_12f427c0-a74a-4af5-ad77-7282d4d70190", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0121-4721", "generic_name": "FLUOXETINE HYDROCHLORIDE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA076015", "marketing_category": "ANDA", "marketing_start_date": "20020201", "listing_expiration_date": "20261231"}