NDC product

FLUOXETINE

NDC 71656-089 · Saptalis Pharmaceuticals, LLC.

Key facts

Product NDC 71656-089
Proprietary name FLUOXETINE
Nonproprietary name FLUOXETINE
Substances FLUOXETINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Saptalis Pharmaceuticals, LLC.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA075525
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
Marketing start Jun 20, 2025
Listing certified through Dec 31, 2026

At a glance

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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