fluoxetine

Generic: fluoxetine

Labeler: dr.reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler dr.reddy's laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Dr.Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-150
Product ID 55111-150_ec5088cd-9e68-ba14-e274-7e3935c87f17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076006
Listing Expiration 2026-12-31
Marketing Start 2016-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111150
Hyphenated Format 55111-150

Supplemental Identifiers

RxCUI
313990
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 ANDA076006 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (55111-150-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-150-30)
  • 10 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79)
source: ndc

Packages (5)

55111-150-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-150-01) 55111-150-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05) 55111-150-10 1000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10) 55111-150-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-150-30) 55111-150-78 10 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79)

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": "ec5088cd-9e68-ba14-e274-7e3935c87f17", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313990"], "spl_set_id": ["11544dea-2f5e-1536-584a-5d1f37a99770"], "manufacturer_name": ["Dr.Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (55111-150-01)", "package_ndc": "55111-150-01", "marketing_start_date": "20160930"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05)", "package_ndc": "55111-150-05", "marketing_start_date": "20160930"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10)", "package_ndc": "55111-150-10", "marketing_start_date": "20160930"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-150-30)", "package_ndc": "55111-150-30", "marketing_start_date": "20160930"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-150-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79)", "package_ndc": "55111-150-78", "marketing_start_date": "20160930"}], "brand_name": "Fluoxetine", "product_id": "55111-150_ec5088cd-9e68-ba14-e274-7e3935c87f17", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "55111-150", "generic_name": "Fluoxetine", "labeler_name": "Dr.Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076006", "marketing_category": "ANDA", "marketing_start_date": "20160930", "listing_expiration_date": "20261231"}