fluoxetine

Generic: fluoxetine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7346
Product ID 0904-7346_6cb4d9cd-a5c3-43da-a5ed-4659b864c9cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2024-02-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047346
Hyphenated Format 0904-7346

Supplemental Identifiers

RxCUI
310384 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 hydrochloride (source: ndc)
Application Number ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7346-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7346-61 100 BLISTER PACK in 1 CARTON (0904-7346-61) / 1 CAPSULE in 1 BLISTER PACK

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": "6cb4d9cd-a5c3-43da-a5ed-4659b864c9cc", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385"], "spl_set_id": ["76b264ce-2a13-4511-8e21-4ffad0a327f9"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7346-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7346-61", "marketing_start_date": "20240221"}], "brand_name": "Fluoxetine", "product_id": "0904-7346_6cb4d9cd-a5c3-43da-a5ed-4659b864c9cc", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0904-7346", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20240221", "listing_expiration_date": "20261231"}