fluoxetine

Generic: fluoxetine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-306
Product ID 65862-306_75e37c2c-4f1b-4660-ae32-0ce8106b12ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079209
Listing Expiration 2026-12-31
Marketing Start 2009-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862306
Hyphenated Format 65862-306

Supplemental Identifiers

RxCUI
310386
UPC
0365862306128
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 ANDA079209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, GLASS (65862-306-12)
source: ndc

Packages (1)

65862-306-12 120 mL in 1 BOTTLE, GLASS (65862-306-12)

Ingredients (1)

fluoxetine hydrochloride (20 mg/5mL)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "75e37c2c-4f1b-4660-ae32-0ce8106b12ff", "openfda": {"upc": ["0365862306128"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["3195db14-0cae-4b49-9fba-49b869fe92a8"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, GLASS (65862-306-12)", "package_ndc": "65862-306-12", "marketing_start_date": "20090319"}], "brand_name": "Fluoxetine", "product_id": "65862-306_75e37c2c-4f1b-4660-ae32-0ce8106b12ff", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "65862-306", "generic_name": "Fluoxetine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA079209", "marketing_category": "ANDA", "marketing_start_date": "20090319", "listing_expiration_date": "20261231"}