fluoxetine

Generic: fluoxetine hydrochloride

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
QUALLENT PHARMACEUTICALS HEALTH LLC

Identifiers & Regulatory

Product NDC 82009-100
Product ID 82009-100_3efc8675-fd3f-463f-8170-a80b6a6fa499
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009100
Hyphenated Format 82009-100

Supplemental Identifiers

RxCUI
310384 310385 313989
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 ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (82009-100-10)
source: ndc

Packages (1)

82009-100-10 1000 CAPSULE in 1 BOTTLE (82009-100-10)

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": "3efc8675-fd3f-463f-8170-a80b6a6fa499", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["4abbd9d9-e9b1-463d-8f39-f3f50d80f58a"], "manufacturer_name": ["QUALLENT PHARMACEUTICALS HEALTH LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (82009-100-10)", "package_ndc": "82009-100-10", "marketing_start_date": "20230901"}], "brand_name": "Fluoxetine", "product_id": "82009-100_3efc8675-fd3f-463f-8170-a80b6a6fa499", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "82009-100", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "QUALLENT PHARMACEUTICALS HEALTH LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}