fluoxetine

Generic: fluoxetine hydrochloride

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler quality care products, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-047
Product ID 83008-047_35052332-06b5-4185-9440-f9d942e57ae9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Marketing Start 2023-12-11
Marketing End 2026-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008047
Hyphenated Format 83008-047

Supplemental Identifiers

RxCUI
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 ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (83008-047-30)
  • 90 CAPSULE in 1 BOTTLE (83008-047-90)
source: ndc

Packages (2)

83008-047-30 30 CAPSULE in 1 BOTTLE (83008-047-30) 83008-047-90 90 CAPSULE in 1 BOTTLE (83008-047-90)

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": "35052332-06b5-4185-9440-f9d942e57ae9", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310385"], "spl_set_id": ["77ae9e44-efb9-4199-ae16-061e13e26080"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (83008-047-30)", "package_ndc": "83008-047-30", "marketing_end_date": "20260731", "marketing_start_date": "20240104"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (83008-047-90)", "package_ndc": "83008-047-90", "marketing_end_date": "20260731", "marketing_start_date": "20231211"}], "brand_name": "Fluoxetine", "product_id": "83008-047_35052332-06b5-4185-9440-f9d942e57ae9", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "83008-047", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20231211"}