fluoxetine

Generic: fluoxetine

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler northstar rx llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-490
Product ID 72603-490_3e1e767b-66a5-4f38-8142-84d40d447f92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603490
Hyphenated Format 72603-490

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0372603488012
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 ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (72603-490-01)
  • 500 CAPSULE in 1 BOTTLE (72603-490-02)
  • 1000 CAPSULE in 1 BOTTLE (72603-490-03)
source: ndc

Packages (3)

72603-490-01 100 CAPSULE in 1 BOTTLE (72603-490-01) 72603-490-02 500 CAPSULE in 1 BOTTLE (72603-490-02) 72603-490-03 1000 CAPSULE in 1 BOTTLE (72603-490-03)

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": "3e1e767b-66a5-4f38-8142-84d40d447f92", "openfda": {"upc": ["0372603488012"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["3e1e767b-66a5-4f38-8142-84d40d447f92"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72603-490-01)", "package_ndc": "72603-490-01", "marketing_start_date": "20250901"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72603-490-02)", "package_ndc": "72603-490-02", "marketing_start_date": "20250901"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (72603-490-03)", "package_ndc": "72603-490-03", "marketing_start_date": "20250901"}], "brand_name": "Fluoxetine", "product_id": "72603-490_3e1e767b-66a5-4f38-8142-84d40d447f92", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72603-490", "generic_name": "Fluoxetine", "labeler_name": "NorthStar Rx LLC", "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": "20250901", "listing_expiration_date": "20261231"}