fluoxetine

Generic: fluoxetine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4428
Product ID 70518-4428_3bb88af7-5af2-8a09-e063-6294a90a61cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213286
Listing Expiration 2026-12-31
Marketing Start 2025-08-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184428
Hyphenated Format 70518-4428

Supplemental Identifiers

RxCUI
248642
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 ANDA213286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4428-0)
source: ndc

Packages (1)

70518-4428-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4428-0)

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": "3bb88af7-5af2-8a09-e063-6294a90a61cf", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["248642"], "spl_set_id": ["58b39e6a-3aae-4551-b081-586a4506aef2"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4428-0)", "package_ndc": "70518-4428-0", "marketing_start_date": "20250806"}], "brand_name": "Fluoxetine", "product_id": "70518-4428_3bb88af7-5af2-8a09-e063-6294a90a61cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70518-4428", "generic_name": "Fluoxetine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA213286", "marketing_category": "ANDA", "marketing_start_date": "20250806", "listing_expiration_date": "20261231"}