fluoxetine

Generic: fluoxetine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler american health packaging
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-845
Product ID 60687-845_31f54f70-b632-cb9e-e063-6394a90a329f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079209
Listing Expiration 2026-12-31
Marketing Start 2024-12-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687845
Hyphenated Format 60687-845

Supplemental Identifiers

RxCUI
310386
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 (source: ndc)
Application Number ANDA079209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (60687-845-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40)
source: ndc

Packages (1)

60687-845-77 4 TRAY in 1 CASE (60687-845-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40)

Ingredients (1)

fluoxetine hydrochloride (20 mg/5mL)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31f54f70-b632-cb9e-e063-6394a90a329f", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["3276a2a4-61c7-4de6-b519-3aa8b62da88f"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (60687-845-77)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46)  / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40)", "package_ndc": "60687-845-77", "marketing_start_date": "20241204"}], "brand_name": "Fluoxetine", "product_id": "60687-845_31f54f70-b632-cb9e-e063-6394a90a329f", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "60687-845", "generic_name": "Fluoxetine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA079209", "marketing_category": "ANDA", "marketing_start_date": "20241204", "listing_expiration_date": "20261231"}