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 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-570
Product ID 43063-570_41395b4d-cdfe-88a7-e063-6294a90ad60c
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 43063570
Hyphenated Format 43063-570

Supplemental Identifiers

RxCUI
310384
UPC
0343063570906
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
  • 10 mg/1
source: ndc
Packaging
  • 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-21)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-28)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-90)
source: ndc

Packages (4)

43063-570-21 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-21) 43063-570-28 28 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-28) 43063-570-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-30) 43063-570-90 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-90)

Ingredients (1)

fluoxetine hydrochloride (10 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": "41395b4d-cdfe-88a7-e063-6294a90ad60c", "openfda": {"upc": ["0343063570906"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384"], "spl_set_id": ["7d7a196b-91de-4753-8bb6-c6d5c668952d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-21)", "package_ndc": "43063-570-21", "marketing_start_date": "20170201"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-28)", "package_ndc": "43063-570-28", "marketing_start_date": "20160127"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-30)", "package_ndc": "43063-570-30", "marketing_start_date": "20150414"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-90)", "package_ndc": "43063-570-90", "marketing_start_date": "20150414"}], "brand_name": "Fluoxetine", "product_id": "43063-570_41395b4d-cdfe-88a7-e063-6294a90ad60c", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43063-570", "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": "10 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20080131", "listing_expiration_date": "20261231"}