fluoxetine

Generic: fluoxetine

Labeler: saptalis pharmaceuticals, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler saptalis pharmaceuticals, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
Saptalis Pharmaceuticals, LLC.

Identifiers & Regulatory

Product NDC 71656-089
Product ID 71656-089_38420669-08b4-a3e4-e063-6294a90a4573
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075525
Listing Expiration 2026-12-31
Marketing Start 2025-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71656089
Hyphenated Format 71656-089

Supplemental Identifiers

RxCUI
310386
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 (source: ndc)
Application Number ANDA075525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (71656-089-04)
source: ndc

Packages (1)

71656-089-04 120 mL in 1 BOTTLE (71656-089-04)

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": "38420669-08b4-a3e4-e063-6294a90a4573", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["4527c502-b28c-449f-ad2d-7daf21563cfa"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (71656-089-04)", "package_ndc": "71656-089-04", "marketing_start_date": "20250620"}], "brand_name": "FLUOXETINE", "product_id": "71656-089_38420669-08b4-a3e4-e063-6294a90a4573", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71656-089", "generic_name": "FLUOXETINE", "labeler_name": "Saptalis Pharmaceuticals, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA075525", "marketing_category": "ANDA", "marketing_start_date": "20250620", "listing_expiration_date": "20261231"}