fluoxetine

Generic: fluoxetine hydrochloride

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler direct rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-067
Product ID 72189-067_2be78ca4-349b-418a-e063-6294a90a0b01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2020-01-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189067
Hyphenated Format 72189-067

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 (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (72189-067-30)
  • 90 CAPSULE in 1 BOTTLE (72189-067-90)
source: ndc

Packages (2)

72189-067-30 30 CAPSULE in 1 BOTTLE (72189-067-30) 72189-067-90 90 CAPSULE in 1 BOTTLE (72189-067-90)

Ingredients (1)

fluoxetine hydrochloride (40 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": "2be78ca4-349b-418a-e063-6294a90a0b01", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["9b8d8da5-8c06-0942-e053-2995a90aa2c9"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72189-067-30)", "package_ndc": "72189-067-30", "marketing_start_date": "20200107"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (72189-067-90)", "package_ndc": "72189-067-90", "marketing_start_date": "20200107"}], "brand_name": "FLUOXETINE", "product_id": "72189-067_2be78ca4-349b-418a-e063-6294a90a0b01", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72189-067", "generic_name": "FLUOXETINE HYDROCHLORIDE", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20200107", "listing_expiration_date": "20261231"}