fluoxetine

Generic: fluoxetine hydrochloride

Labeler: vensun pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler vensun pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
Vensun Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 42543-727
Product ID 42543-727_f1764ef9-4324-4e97-a72c-d54bb09245ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2015-03-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42543727
Hyphenated Format 42543-727

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0342543725300 0342543726307 0342543726017 0342543725010 0342543727304
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
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42543-727-01)
  • 500 CAPSULE in 1 BOTTLE (42543-727-05)
  • 30 CAPSULE in 1 BOTTLE (42543-727-30)
source: ndc

Packages (3)

42543-727-01 100 CAPSULE in 1 BOTTLE (42543-727-01) 42543-727-05 500 CAPSULE in 1 BOTTLE (42543-727-05) 42543-727-30 30 CAPSULE in 1 BOTTLE (42543-727-30)

Ingredients (1)

fluoxetine hydrochloride (40 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": "f1764ef9-4324-4e97-a72c-d54bb09245ba", "openfda": {"upc": ["0342543725300", "0342543726307", "0342543726017", "0342543725010", "0342543727304"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["b4f37ef1-8f5e-4318-90f1-2d8f8afb669c"], "manufacturer_name": ["Vensun Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42543-727-01)", "package_ndc": "42543-727-01", "marketing_start_date": "20150316"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42543-727-05)", "package_ndc": "42543-727-05", "marketing_start_date": "20150316"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42543-727-30)", "package_ndc": "42543-727-30", "marketing_start_date": "20150316"}], "brand_name": "Fluoxetine", "product_id": "42543-727_f1764ef9-4324-4e97-a72c-d54bb09245ba", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "42543-727", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Vensun Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20150316", "listing_expiration_date": "20261231"}