fluoxetine

Generic: fluoxetine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-993
Product ID 43063-993_415f88da-1cac-b284-e063-6394a90a8b70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2008-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063993
Hyphenated Format 43063-993

Supplemental Identifiers

RxCUI
313989
UPC
0343063993903
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
  • 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-21)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-90)
source: ndc

Packages (3)

43063-993-21 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-21) 43063-993-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-30) 43063-993-90 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-90)

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": "415f88da-1cac-b284-e063-6394a90a8b70", "openfda": {"upc": ["0343063993903"], "unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-21)", "package_ndc": "43063-993-21", "marketing_start_date": "20241211"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-30)", "package_ndc": "43063-993-30", "marketing_start_date": "20190620"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (43063-993-90)", "package_ndc": "43063-993-90", "marketing_start_date": "20190708"}], "brand_name": "Fluoxetine", "product_id": "43063-993_415f88da-1cac-b284-e063-6394a90a8b70", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43063-993", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20080131", "listing_expiration_date": "20261231"}