fluoxetine

Generic: fluoxetine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 60 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2201
Product ID 63629-2201_ff509ee8-400d-4128-aab8-5b389dd7f082
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209419
Listing Expiration 2026-12-31
Marketing Start 2017-11-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636292201
Hyphenated Format 63629-2201

Supplemental Identifiers

RxCUI
1190110
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 (source: ndc)
Application Number ANDA209419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-2201-1)
source: ndc

Packages (1)

63629-2201-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-2201-1)

Ingredients (1)

fluoxetine hydrochloride (60 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": "ff509ee8-400d-4128-aab8-5b389dd7f082", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["10293946-5a06-4c21-9f78-941be360b09b"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-2201-1)", "package_ndc": "63629-2201-1", "marketing_start_date": "20221028"}], "brand_name": "Fluoxetine", "product_id": "63629-2201_ff509ee8-400d-4128-aab8-5b389dd7f082", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63629-2201", "generic_name": "Fluoxetine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA209419", "marketing_category": "ANDA", "marketing_start_date": "20171116", "listing_expiration_date": "20261231"}