fluoxetine hcl

Generic: fluoxetine hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hcl
Generic Name fluoxetine hcl
Labeler direct_rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-505
Product ID 72189-505_2c4e5941-7088-8be7-e063-6394a90a92e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2023-08-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189505
Hyphenated Format 72189-505

Supplemental Identifiers

RxCUI
313989
UNII
I9W7N6B1KJ

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 hcl (source: ndc)
Generic Name fluoxetine hcl (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (72189-505-30)
source: ndc

Packages (1)

72189-505-30 30 CAPSULE in 1 BOTTLE (72189-505-30)

Ingredients (1)

fluoxetine hydrochloride (40 mg/1)

Linked Drug Pages (1)

Fluoxetine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4e5941-7088-8be7-e063-6394a90a92e3", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["0259db51-e1ff-6e7a-e063-6394a90abace"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72189-505-30)", "package_ndc": "72189-505-30", "marketing_start_date": "20230807"}], "brand_name": "Fluoxetine HCL", "product_id": "72189-505_2c4e5941-7088-8be7-e063-6394a90a92e3", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72189-505", "generic_name": "Fluoxetine HCL", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine HCL", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20230807", "listing_expiration_date": "20261231"}