fluoxetine

Generic: fluoxetine hydrochloride

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 60 mg/1

Manufacturer
NIVAGEN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 75834-148
Product ID 75834-148_3ca13da1-2f1e-5165-e063-6394a90a17fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209695
Listing Expiration 2026-12-31
Marketing Start 2017-12-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834148
Hyphenated Format 75834-148

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 (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA209695 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (75834-148-30)
source: ndc

Packages (1)

75834-148-30 30 TABLET in 1 BOTTLE (75834-148-30)

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": "3ca13da1-2f1e-5165-e063-6394a90a17fc", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["f4cbf9a9-1d7f-4aa0-a18d-fba50d49bd2b"], "manufacturer_name": ["NIVAGEN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (75834-148-30)", "package_ndc": "75834-148-30", "marketing_start_date": "20171211"}], "brand_name": "fluoxetine", "product_id": "75834-148_3ca13da1-2f1e-5165-e063-6394a90a17fc", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "75834-148", "generic_name": "fluoxetine hydrochloride", "labeler_name": "NIVAGEN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA209695", "marketing_category": "ANDA", "marketing_start_date": "20171211", "listing_expiration_date": "20261231"}