fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

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

Drug Facts

Product Profile

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

fluoxetine hydrochloride 60 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-632
Product ID 43598-632_716e99cb-d17e-d5ca-61aa-3298ab7fee96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211721
Listing Expiration 2026-12-31
Marketing Start 2019-01-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598632
Hyphenated Format 43598-632

Supplemental Identifiers

RxCUI
1190110
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 hydrochloride (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA211721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (43598-632-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-632-30)
source: ndc

Packages (2)

43598-632-01 100 TABLET, FILM COATED in 1 BOTTLE (43598-632-01) 43598-632-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-632-30)

Ingredients (1)

fluoxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Fluoxetine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "716e99cb-d17e-d5ca-61aa-3298ab7fee96", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["80e52273-9741-6aef-eb24-8a93ead85ba7"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (43598-632-01)", "package_ndc": "43598-632-01", "marketing_start_date": "20190128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-632-30)", "package_ndc": "43598-632-30", "marketing_start_date": "20190128"}], "brand_name": "Fluoxetine hydrochloride", "product_id": "43598-632_716e99cb-d17e-d5ca-61aa-3298ab7fee96", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43598-632", "generic_name": "Fluoxetine hydrochloride", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine hydrochloride", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211721", "marketing_category": "ANDA", "marketing_start_date": "20190128", "listing_expiration_date": "20261231"}