fluoxetine

Generic: fluoxetine

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8618
Product ID 68788-8618_ee9d16c2-6ec0-4324-a029-1b4e73c093fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201336
Listing Expiration 2026-12-31
Marketing Start 2024-03-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888618
Hyphenated Format 68788-8618

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 (source: ndc)
Application Number ANDA201336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68788-8618-1)
  • 30 CAPSULE in 1 BOTTLE (68788-8618-3)
  • 90 CAPSULE in 1 BOTTLE (68788-8618-6)
source: ndc

Packages (3)

68788-8618-1 100 CAPSULE in 1 BOTTLE (68788-8618-1) 68788-8618-3 30 CAPSULE in 1 BOTTLE (68788-8618-3) 68788-8618-6 90 CAPSULE in 1 BOTTLE (68788-8618-6)

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": "ee9d16c2-6ec0-4324-a029-1b4e73c093fd", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["54ded68c-1d2e-453d-b155-84c3102e1f0e"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68788-8618-1)", "package_ndc": "68788-8618-1", "marketing_start_date": "20240328"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8618-3)", "package_ndc": "68788-8618-3", "marketing_start_date": "20240328"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8618-6)", "package_ndc": "68788-8618-6", "marketing_start_date": "20240328"}], "brand_name": "FLUOXETINE", "product_id": "68788-8618_ee9d16c2-6ec0-4324-a029-1b4e73c093fd", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68788-8618", "generic_name": "FLUOXETINE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA201336", "marketing_category": "ANDA", "marketing_start_date": "20240328", "listing_expiration_date": "20261231"}