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 40 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7198
Product ID 0093-7198_61c76dc7-bc11-4dec-bf02-b4ef5474cbb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075452
Listing Expiration 2026-12-31
Marketing Start 2002-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00937198
Hyphenated Format 0093-7198

Supplemental Identifiers

RxCUI
313989
UPC
0300937198567
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 ANDA075452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0093-7198-01)
  • 500 CAPSULE in 1 BOTTLE (0093-7198-05)
  • 30 CAPSULE in 1 BOTTLE (0093-7198-56)
source: ndc

Packages (3)

0093-7198-01 100 CAPSULE in 1 BOTTLE (0093-7198-01) 0093-7198-05 500 CAPSULE in 1 BOTTLE (0093-7198-05) 0093-7198-56 30 CAPSULE in 1 BOTTLE (0093-7198-56)

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": "61c76dc7-bc11-4dec-bf02-b4ef5474cbb3", "openfda": {"upc": ["0300937198567"], "unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["369dbfba-9de4-433c-8680-2ec047b8f8d9"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0093-7198-01)", "package_ndc": "0093-7198-01", "marketing_start_date": "20080908"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0093-7198-05)", "package_ndc": "0093-7198-05", "marketing_start_date": "20080923"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0093-7198-56)", "package_ndc": "0093-7198-56", "marketing_start_date": "20020130"}], "brand_name": "Fluoxetine", "product_id": "0093-7198_61c76dc7-bc11-4dec-bf02-b4ef5474cbb3", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0093-7198", "generic_name": "Fluoxetine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA075452", "marketing_category": "ANDA", "marketing_start_date": "20020130", "listing_expiration_date": "20261231"}