fluoxetine

Generic: fluoxetine hydrochloride

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

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler westminster pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-235
Product ID 69367-235_2c8c16fd-61b1-4d89-bbc5-66d4d7c0a770
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Marketing Start 2019-09-25
Marketing End 2026-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367235
Hyphenated Format 69367-235

Supplemental Identifiers

RxCUI
310384 310385 313989
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 hydrochloride (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69367-235-01)
  • 1000 CAPSULE in 1 BOTTLE (69367-235-10)
source: ndc

Packages (2)

69367-235-01 100 CAPSULE in 1 BOTTLE (69367-235-01) 69367-235-10 1000 CAPSULE in 1 BOTTLE (69367-235-10)

Ingredients (1)

fluoxetine hydrochloride (10 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": "2c8c16fd-61b1-4d89-bbc5-66d4d7c0a770", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["8c4b2119-8cec-4b4b-9a52-ae763fd9b252"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69367-235-01)", "package_ndc": "69367-235-01", "marketing_end_date": "20260801", "marketing_start_date": "20190925"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (69367-235-10)", "package_ndc": "69367-235-10", "marketing_end_date": "20260801", "marketing_start_date": "20190925"}], "brand_name": "Fluoxetine", "product_id": "69367-235_2c8c16fd-61b1-4d89-bbc5-66d4d7c0a770", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69367-235", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_end_date": "20260801", "marketing_start_date": "20190925"}