fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hydrochloride
Generic Name fluoxetine hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form FOR SOLUTION
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6032
Product ID 0832-6032_178bf3b7-fdee-454e-9446-822a1077d985
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216953
Listing Expiration 2026-12-31
Marketing Start 2022-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326032
Hyphenated Format 0832-6032

Supplemental Identifiers

RxCUI
310386
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 ANDA216953 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

0832-6032-12 1 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLE

Ingredients (1)

fluoxetine hydrochloride (20 mg/5mL)

Linked Drug Pages (1)

Fluoxetine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "178bf3b7-fdee-454e-9446-822a1077d985", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["be2e4325-feb9-4957-99c0-0a741a2d71a0"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0832-6032-12)  / 120 mL in 1 BOTTLE", "package_ndc": "0832-6032-12", "marketing_start_date": "20221130"}], "brand_name": "Fluoxetine hydrochloride", "product_id": "0832-6032_178bf3b7-fdee-454e-9446-822a1077d985", "dosage_form": "FOR SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0832-6032", "generic_name": "Fluoxetine hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine hydrochloride", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA216953", "marketing_category": "ANDA", "marketing_start_date": "20221115", "listing_expiration_date": "20261231"}