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
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2785
Product ID 71335-2785_f197b0ee-0e93-4639-9c5a-17cff936b036
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212684
Listing Expiration 2026-12-31
Marketing Start 2024-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352785
Hyphenated Format 71335-2785

Supplemental Identifiers

RxCUI
248642
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 ANDA212684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71335-2785-1)
source: ndc

Packages (1)

71335-2785-1 100 TABLET in 1 BOTTLE (71335-2785-1)

Ingredients (1)

fluoxetine hydrochloride (20 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": "f197b0ee-0e93-4639-9c5a-17cff936b036", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["248642"], "spl_set_id": ["651e8c32-4519-4619-854f-4be03c6240b6"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-2785-1)", "package_ndc": "71335-2785-1", "marketing_start_date": "20250818"}], "brand_name": "FLUOXETINE", "product_id": "71335-2785_f197b0ee-0e93-4639-9c5a-17cff936b036", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71335-2785", "generic_name": "fluoxetine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA212684", "marketing_category": "ANDA", "marketing_start_date": "20240812", "listing_expiration_date": "20261231"}