fluoxetine

Generic: fluoxetine

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

Drug Facts

Product Profile

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

fluoxetine hydrochloride 10 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 50111-647
Product ID 50111-647_424ed364-e023-472f-b113-673e9342a7f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076001
Listing Expiration 2026-12-31
Marketing Start 2002-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50111647
Hyphenated Format 50111-647

Supplemental Identifiers

RxCUI
310384 310385
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 (source: ndc)
Application Number ANDA076001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (50111-647-01)
  • 500 CAPSULE in 1 BOTTLE (50111-647-02)
  • 1000 CAPSULE in 1 BOTTLE (50111-647-03)
source: ndc

Packages (3)

50111-647-01 100 CAPSULE in 1 BOTTLE (50111-647-01) 50111-647-02 500 CAPSULE in 1 BOTTLE (50111-647-02) 50111-647-03 1000 CAPSULE in 1 BOTTLE (50111-647-03)

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": "424ed364-e023-472f-b113-673e9342a7f1", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (50111-647-01)", "package_ndc": "50111-647-01", "marketing_start_date": "20020129"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (50111-647-02)", "package_ndc": "50111-647-02", "marketing_start_date": "20020129"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (50111-647-03)", "package_ndc": "50111-647-03", "marketing_start_date": "20020129"}], "brand_name": "Fluoxetine", "product_id": "50111-647_424ed364-e023-472f-b113-673e9342a7f1", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50111-647", "generic_name": "Fluoxetine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076001", "marketing_category": "ANDA", "marketing_start_date": "20020129", "listing_expiration_date": "20261231"}